This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

Size: px
Start display at page:

Download "This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data."

Transcription

1 abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical study report had been prepared in accordance with best practice and applicable legal and regulatory requirements at the time of study completion. The synopsis may include approved and non approved uses, doses, formulations, treatment regimens and/or age groups; it has not necessarily been submitted to regulatory authorities. A synopsis is not intended to provide a comprehensive analysis of all data currently available regarding a particular drug. More current information regarding a drug is available in the approved labeling information which may vary from country to country.. Additional information on this study and the drug concerned may be provided upon request based on s Policy on Transparency and Publication of Clinical Study Data. The synopsis is supplied for informational purposes only in the interests of scientific disclosure. It must not be used for any commercial purposes and must not be distributed, published, modified, reused, posted in any way, or used for any other purpose without the express written permission of.

2

3 Page 2 of 10 BI Trial No.: c International GmbH or one or more of its affiliated companies 2 of International GmbH or one or more of its affiliated companies. All rights reserved. Table 1: Patients entered, treated, and analysed (primary endpoint) Entered Treated Analysed Placebo Tiotropium 5 µg Tio+Olo 2.5/5 µg Tio+Olo 5/5 µg Diagnosis: Main Criteria for Inclusion: BI Investigational Product: Dose: Mode of Admin.: Batch No.: BI Investigational Product: Dose: Mode of Admin.: Batch No.: COPD Outpatients with COPD 40 years old, smoking history of >10 pack years, postbronchodilator FEV 1 30% and <80% of predicted normal, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II III, and post-bronchodilator FEV 1 / forced vital capacity (FVC) <70%. Tiotropium+Olodaterol (Tio+Olo) inhalation solution - RESPIMAT 2.5 μg tiotropium / 5 μg olodaterol (1.25 μg µg, respectively, per actuation Oral inhalation B Tio+Olo inhalation solution - RESPIMAT 5 μg tiotropium / 5 μg olodaterol (2.5 µg each per actuation) Oral inhalation B

4 Page 3 of 10 BI Trial No.: c International GmbH or one or more of its affiliated companies 3 of International GmbH or one or more of its affiliated companies. All rights reserved. Comparator Product: Dose: Mode of Admin.: Batch No.: Comparator Product: Dose: Mode of Admin.: Batch No.: Duration of Treatment: Criteria for Evaluation: Efficacy: Safety: Tiotropium inhalation solution - RESPIMAT 5 μg (2.5 µg per actuation) Oral inhalation B Placebo inhalation solution RESPIMAT Oral inhalation B weeks. The duration of the trial for each patient was 18 weeks: 1-week run-in period, 2-week screening period, 12-week treatment period, and 3-week follow-up period Primary efficacy endpoints: FEV 1 area under the curve (AUC) 0-3h response (change from baseline) after 12 weeks of treatment Trough FEV 1 response (change from baseline) after 12 weeks of treatment SGRQ total score after 12 weeks of treatment Secondary efficacy endpoints: Transitional Dyspnoea Index (TDI) focal score after 12 weeks of treatment FVC AUC 0-3h response (change from baseline) after 12 weeks of treatment Trough FVC response (change from baseline) after 12 weeks of treatment Further (non-secondary) endpoints are not presented here. The assessment of safety was based on routine safety monitoring and reporting through adverse events, serious adverse events, physical examination, pulse rate and blood pressure pre-dose and post-dose at Visits 2 and 5, and treatment exposure.

5 Page 4 of 10 BI Trial No.: c International GmbH or one or more of its affiliated companies 4 of International GmbH or one or more of its affiliated companies. All rights reserved. Statistical Methods: SUMMARY - CONCLUSIONS: Trial Subjects and Compliance with Trial Protocol: The primary analysis was performed on the full analysis set (FAS). Comparisons between treatment groups for change from baseline in FEV 1 AUC 0-3h, change from baseline in trough FEV 1, and SGRQ total score were analysed using a restricted maximum likelihood (REML)-based mixed effects model for repeated measures (MMRM) approach. The MMRM model included treatment, test day and treatment by test day interaction as fixed, categorical effects, baseline and baseline-by-test day interaction as continuous fixed covariates, and patient as random effect. A spatial power (co)variance structure was used to model the within-patient errors. The Kenward-Roger approximation was used to estimate denominator degrees of freedom. Adjusted mean values were presented together with p-values and 95% confidence intervals (CI). The empirical sandwich estimator approach was used as sensitivity analysis. For the 3 primary endpoints, Tio+Olo 5/5 µg and Tio+Olo 2.5/5 µg were tested vs. placebo in a pre-defined sequential testing scheme. For the third primary endpoint, SGRQ total score, the data from this trial ( ) were also combined with data from the replicate trial ( ). The primary treatment comparison was the contrast between treatment groups after 12 weeks of treatment. Statistical significance was declared if 2-sided hypothesis tests were rejected at the 0.05 significance level, the treatment effect favoured the Tio+Olo fixed dose combination (FDC) vs. placebo, and all previous hypothesis tests in the pre-defined hierarchy had shown statistical significance. Further comparisons between treatment groups (i.e. Tio+Olo 5/5 µg and Tio+Olo 2.5/5 µg vs. Tio 5 µg, Tio 5 µg vs. placebo, and Tio+Olo 5/5 µg vs. Tio+Olo 2.5/5) were performed as descriptive analyses (i.e. not protected by the overall type I error at the 0.05 level). A total of 809 patients were randomised and treated. Of these, 764 patients (94.4%) completed the trial and 45 patients (5.6%) discontinued study medication prematurely. The only reason for premature discontinuation reported for >1% of patients was occurrence of adverse events (AEs, 2.8% overall). Premature study medication discontinuation was more frequent in the placebo group (9.9%) than in the active treatment groups (tiotropium [Tio] 5 µg: 5.9%, tiotropium + olodaterol

6 Page 5 of 10 BI Trial No.: c International GmbH or one or more of its affiliated companies 5 of International GmbH or one or more of its affiliated companies. All rights reserved. Efficacy Results: [T+O] 5/5 µg: 2.0%, T+O 2.5/5 µg: 4.5%). Twenty-two of the 809 treated patients (2.7%) had at least 1 important protocol violation (IPV) during the trial. The incidence of IPVs was similar in all treatment groups (2.0 to 3.5%). Demographic characteristics were generally well balanced among the 4 treatment groups. The majority of patients were White (96.3%) and male (62.5%). The percentage of male patients was slightly lower in the placebo group (57.9%) than in the active treatment groups (62.4% to 65.8%). The overall mean age was 64.6 years (standard deviation 8.4 years). In line with the inclusion criteria, all patients were aged 40 years (range 41 to 92 years), and all were ex-smokers (54.5%) or current smokers (45.5%). The overall mean smoking history was 49.3 pack-years (range 11 to 208 pack-years). Efficacy results from lung function endpoints presented in this report are based on analyses of the data from trial Efficacy results from SGRQ and Mahler TDI score endpoints presented in this report are based on both the individual dataset from trial and the combined dataset from and Primary efficacy endpoints: The primary lung function endpoints for this trial were the FEV 1 AUC 0-3h response (change from baseline) and trough FEV 1 response assessed after 12 weeks of treatment (based on the individual data from this trial). The primary symptomatic endpoint was the SGRQ total score after 12 weeks of treatment based on the individual data from this trial as well as the combined data from this trial and the replicate trial The Tio+Olo FDCs were superior to placebo for both primary lung function endpoints and for the primary symptomatic endpoint (p<0.05, 2-sided) based on all pre-defined hypothesis tests. Sensitivity analyses yielded similar results to those of the primary analyses. The adjusted mean FEV 1 AUC 0-3h responses after 12 weeks were larger for the Tio+Olo FDCs than for placebo or Tio 5 µg (placebo: [standard error [SE] [ 0.4] L, Tio 5 μg: [0.3] L, T+O 2.5/5 μg: [0.4] L, T+O 5/5 μg: [0.3] L). The improvement over placebo after 12 weeks was L for Tio+Olo 5/5 µg and L for Tio+Olo 2.5/5 µg (p<0.00 for both

7 Page 6 of 10 BI Trial No.: c International GmbH or one or more of its affiliated companies 6 of International GmbH or one or more of its affiliated companies. All rights reserved. comparisons). The adjusted mean trough FEV 1 responses after 12 weeks were also larger for the Tio+Olo FDCs than for placebo or Tio 5 µg (placebo: [SE 0.4] L, Tio 5 μg: [0.3] L, T+O 2.5/5 μg: [0.3] L, T+O 5/5 μg: [0.3] L). The improvement over placebo was L for Tio+Olo 5/5 μg and L for Tio+Olo 2.5/5 μg (p<0.00 for both comparisons). The adjusted mean SGRQ total score after 12 weeks of treatment was lower (better) for the Tio+Olo FDCs than for placebo or Tio 5 µg in both, the individual trial data from (placebo: , [SE 0.711] points, Tio 5 μg: [0.694] points, T+O 2.5/5 μg: [0.691] points, T+O 5/5 μg: 38.1 [0.683] points) and the combined trial data (placebo: [0.511] points, Tio 5 μg: [0.498] points, T+O 2.5/5 μg: [0.494] points, T+O 5/5 μg: [0.492] points). The scores obtained from both data sources (individual and combined data) were comparable. Based on the data from trial , the treatment difference in the adjusted mean SGRQ total score was points for Tio+Olo 5/5 μg vs. placebo and points for Tio+Olo 2.5/5 μg vs. placebo (p<0.00 and p = , respectively). Based on the combined data, the treatment difference in the adjusted mean SGRQ total score was points for Tio+Olo 5/5 μg vs. placebo and points for Tio+Olo 2.5/5 μg vs. placebo (p<0.00 for both comparisons). Consequently, all confirmatory hypotheses were met in this trial. The type I error was protected only for the above comparisons. The following comparisons were not included in the hierarchical testing sequence and were therefore considered descriptive (nominal p-values). The treatment difference for Tio 5 µg vs. placebo was L for FEV 1 AUC 0-3h response and L for trough FEV 1 response ( p<0.00 for both lung function endpoints). The treatment difference for the adjusted mean SGRQ total score for Tio 5 µg vs. placebo was points based on individual trial data from and points based on combined data (p = and p = , respectively). Treatment differences in favour of the FDCs compared with Tio 5 µg were observed for FEV 1 AUC 0-3h response (0.105 L for T+O 5/5 µg and L for T+O 2.5/5 µg vs. Tio 5 µg, p<0.00 for both comparisons) and for trough FEV 1

8 Page 7 of 10 BI Trial No.: c International GmbH or one or more of its affiliated companies 7 of International GmbH or one or more of its affiliated companies. All rights reserved. response (0.039 L for T+O 5/5 µg and L for T+O 2.5/5 µg vs. Tio 5 µg, p = and p = , respectively). Treatment differences in favour of the FDCs compared with Tio 5 µg were also observed for the SGRQ total score for both, the individual trial data from ( points for T+O 5/5 µg and points for T+O 2.5/5 µg vs. Tio 5 µg, p = and p = , respectively) and the combined data( points for Tio+Olo 5/5 µg and points for Tio+Olo 2.5/5 µg vs. Tio 5 µg, p = and p = , respectively). Secondary efficacy endpoints: The analyses of secondary endpoints are descriptive, and p-values for treatment comparisons are nominal. TDI focal score after 12 weeks of treatment The adjusted mean TDI focal score after 12 weeks of treatment was higher (better) for the Tio+Olo FDCs than for placebo or Tio 5 µg in both, the individual trial data from (placebo: [SE 0.195] points, Tio 5 μg: [0.191] points, T+O 2.5/5 μg: [0.189] points, T+O 5/5 μg: [0.187] points) and the combined trial data (placebo: [0.139] points, Tio 5 μg: [0.136] points, T+O 2.5/5 μg: [0.134] points, T+O 5/5 μg: [0.134] points). The scores obtained from both data sources (individual and combined data) were comparable. Based on individual trial data from , the treatment difference was points for Tio+Olo 5/5 µg vs. placebo and points for Tio+Olo 2.5/5 µg vs. placebo (p<0.00 for both comparisons). The treatment difference for Tio 5 µg vs. placebo was points (p = ). Based on combined data, the treatment difference was points for Tio+Olo 5/5 µg vs. placebo and 1.611points for Tio+Olo 2.5/5 µg vs. placebo; the treatment difference for Tio 5 µg vs. placebo was points (p<0.00 for all comparisons). Treatment differences in favour of the FDCs compared with Tio 5 µg were observed for both, the individual trial data from (0.582 points for T+O 5/5 µg and points for T+O 2.5/5 µg vs. Tio 5 µg, p = and p = 0.59, respectively) and the combined data (0.594 points for T+O 5/5 µg and

9 Page 8 of 10 BI Trial No.: c International GmbH or one or more of its affiliated companies 8 of International GmbH or one or more of its affiliated companies. All rights reserved. Safety Results: points for T+O 2.5/5 µg vs. Tio 5 µg, p = 0.09 and p = , respectively). FVC AUC 0-3h response and trough FVC response (changes from baseline) after 12 weeks of treatment The results for the adjusted mean FVC AUC 0-3h responses after 12 weeks of treatment were in line with the FEV 1 data and were clearly larger for the 2 FDCs than for placebo and Tio 5 µg (placebo: -0.8, [SE 0.025] L, Tio 5 μg: [0.023] L, T+O 2.5/5 μg: [0.024] L, T+O 5/5 μg: [0.023] L). The difference to placebo was L for Tio+Olo 5/5 μg and L for Tio+Olo 2.5/5 µg (p<0.00 for both comparisons). The adjusted mean trough FVC responses showed a similar pattern (placebo: [SE 0.024] L, Tio 5 μg: [0.023] L, T+O 2.5/5 μg: [0.023] L, T+O 5/5 μg: [0.023] L). The difference to placebo was L for Tio+Olo 5/5 μg and L for Tio+Olo 2.5/5 μg (p<0.00 for both comparisons). The treatment differences for Tio 5 µg vs. placebo were L for the FVC AUC 0-3h response and L for the trough FVC response (p<0.00 for both lung function endpoints). Treatment differences in favour of the FDCs compared with Tio 5 µg were observed for FVC AUC 0-3h response (0.148 L for Tio+Olo 5/5 µg and L for Tio+Olo 2.5/5 µg vs. Tio 5 µg, p<0.00 for both comparisons) and for trough FVC response (0.061 L for Tio+Olo 5/5 µg and L for Tio+Olo 2.5/5 µg vs. Tio 5 µg, p = and p = , respectively). Further (non-secondary) endpoints are not presented here. Overall, 45.1% of patients reported at least 1 AE during the trial, and the incidence was similar between the treatment groups (placebo: 46.0%, Tio 5 μg: 45.8%, T+O 2.5/5 μg: 45.5%, T+O 5/5 μg: 43.1%). Consistent with the population under study, the most frequently reported AEs by SOC were respiratory, thoracic and mediastinal disorders (16.2% overall) and infections and infestations (15.7% overall). AEs reported for more than 2.0% of patients overall were COPD (lowest level term COPD exacerbation; 6.2%), nasopharyngitis (4.3%), cough (3.1%), dyspnoea (3.0%), and upper respiratory

10 Page 9 of 10 BI Trial No.: c International GmbH or one or more of its affiliated companies 9 of International GmbH or one or more of its affiliated companies. All rights reserved. tract infection (2.3%). The incidence of cough and dyspnoea was higher in the placebo group than in the active treatment groups; for other common AEs, incidences were generally comparable across the treatment groups, and there was no indication of a tiotropium dose relationship for the combination therapies. The majority of AEs were mild to moderate in intensity; severe AEs were reported for 22 patients (2.7%) overall, with similar frequencies in the T+O 5/5 μg and placebo groups. Drug-related AEs (as assessed by the investigator) were reported for 35 patients (4.3%) overall. The most commonly reported related AEs were cough, reported for 6 patients (0.7%), and dyspnoea and COPD, each reported for 4 patients (0.5%). There were no noteworthy differences between the treatment groups with regard to specific drug-related AEs. One patient died during the trial (T+O 5/5 µg group). The fatal AE (myocardial infarction) was not considered to be drug-related by the investigator. Overall, 26 patients (3.2%) experienced at least 1 serious adverse event (SAE) during the treatment period (placebo: 2.0%, Tio 5 μg: 5.9%, T+O 2.5/5 μg: 2.0%, T+O 5/5 μg: 3.0%). The most frequent SAEs by SOC were cardiac disorders, reported for a total of 7 patients (0.9%): 3 patients each in the Tio 5 µg and Tio+Olo 5/5 µg groups, and 1 patient in the placebo group. SAEs that were reported for more than 2 patients overall were myocardial infarction, COPD, and musculoskeletal chest pain (3 patients each). One case of myocardial infarction in the Tio+Olo 5/5 µg group was fatal. All but one of the patients with cardiac SAEs had pre-existing coronary heart disease and/or cardiovascular risk factors. There were no notable differences between the treatment groups with regard to specific SAEs. SAEs reported for 2 patients (T+O 2.5/5 μg group) were considered to be drug-related by the investigator (cellulitis in 1 patient and rash in 1 patient). A total of 22 patients (2.7%) experienced AEs that led to discontinuation of study medication, with the highest incidence being observed in the placebo group (placebo: 5.0%, Tio 5 μg: 3.4%, T+O 2.5/5 μg: 2.0%, T+O 5/5 μg: 0.5%). AEs leading to treatment discontinuation that were reported for more than 2 patients overall were COPD (7 patients), dyspnoea (5 patients), and cough (3 patients). Vital signs measurements were similar between treatment groups. No dose- or time- related trends or patterns were observed.

11 Page 10 of 10 BI Trial No.: c International GmbH or one or more of its affiliated companies 10 of International GmbH or one or more of its affiliated companies. All rights reserved. Conclusions: With respect to the lung function primary endpoints (FEV 1 AUC 0-3h response, trough FEV 1 response after 12 weeks), trial confirmed the benefit of Tio+Olo 5/5 μg and Tio+Olo 2.5/5 μg compared with placebo. With respect to the symptomatic primary endpoint (SGRQ total score after 12 weeks), trial and the combined dataset from and confirmed the benefit of Tio+Olo 5/5 μg compared with placebo, with an effect size greater than the minimum clinically important difference (MCID) of 4.0 points. A benefit of Tio+Olo 2.5/5 μg compared with placebo for the SGRQ total score was also confirmed, however, with an effect size that was below the MCID for both trial and the combined dataset. Tio+Olo 5/5 μg and Tio+Olo 2.5/5 μg were well tolerated; no safety concerns were identified in the trial.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

Sponsor Novartis Pharmaceuticals

Sponsor Novartis Pharmaceuticals Clinical Trial Results Database Page 1 Sponsor Novartis Pharmaceuticals Generic Drug Name Indacaterol Therapeutic Area of Trial Chronic Obstructive Pulmonary Disease (COPD) Indication studied: COPD Study

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. The synopsis

More information

Samer El Rayess, M.D. Internal Medicine, PGY3 29 January 2016

Samer El Rayess, M.D. Internal Medicine, PGY3 29 January 2016 Samer El Rayess, M.D. Internal Medicine, PGY3 29 January 2016 Case Scenario Mr. X., a 50 year old man heavy smoker 80 pack / year known to have -COPD on spiriva at home last exacerbation 9 months ago -Hypertension

More information

Bronchodilators in COPD

Bronchodilators in COPD TSANZSRS Gold Coast 2015 Can average outcomes in COPD clinical trials guide treatment strategies? Long live the FEV1? Christine McDonald Dept of Respiratory and Sleep Medicine Austin Health Institute for

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium salmeterol/fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler ) No. (450/08) GlaxoSmithKline 11 February 2008 The Scottish Medicines Consortium has completed its

More information

ONCE-DAILY TIOTROPIUM RESPIMAT ADD-ON TO ICS ± LABA IMPROVES CONTROL ACROSS ASTHMA SEVERITIES

ONCE-DAILY TIOTROPIUM RESPIMAT ADD-ON TO ICS ± LABA IMPROVES CONTROL ACROSS ASTHMA SEVERITIES SPIRIVA Respimat is approved for use in asthma in the EU, Japan, the USA and many other countries. The label varies by country. Please refer to the local product information ONCE-DAILY TIOTROPIUM RESPIMAT

More information

Clinical Study Report Synopsis

Clinical Study Report Synopsis Clinical Study Report Synopsis A Phase 1, Multi-Centre, Randomised, Vehicle-Controlled, Double-Blinded, Explorative Clinical Trial to Evaluate a Left-Right Design in Adults with Mild to Moderate Atopic

More information

Sponsor. Novartis Generic Drug Name. Vildagliptin. Therapeutic Area of Trial. Type 2 diabetes. Approved Indication. Investigational.

Sponsor. Novartis Generic Drug Name. Vildagliptin. Therapeutic Area of Trial. Type 2 diabetes. Approved Indication. Investigational. Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Investigational Study Number CLAF237A2386 Title A single-center,

More information

PUBLIC SUMMARY DOCUMENT

PUBLIC SUMMARY DOCUMENT PUBLIC SUMMARY DOCUMENT Product: Budesonide with eformoterol fumarate dihydrate, powder for oral inhalation, fixed dose combination, 400 micrograms-12 micrograms per dose, Symbicort Turbuhaler 400/12 Sponsor:

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Sponsor Novartis. Generic Drug Name Secukinumab. Therapeutic Area of Trial Psoriasis. Approved Indication investigational

Sponsor Novartis. Generic Drug Name Secukinumab. Therapeutic Area of Trial Psoriasis. Approved Indication investigational Clinical Trial Results Database Page 2 Sponsor Novartis Generic Drug Name Secukinumab Therapeutic Area of Trial Psoriasis Approved Indication investigational Clinical Trial Results Database Page 3 Study

More information

Clinical Study Report Synopsis. A psoriasis plaque test trial with LP0113 spray in patients with psoriasis vulgaris

Clinical Study Report Synopsis. A psoriasis plaque test trial with LP0113 spray in patients with psoriasis vulgaris This document has been downloaded from \VW'\V.leo-pharma.com subject to the terms of use state on the website. It contains data and results regarding approved and non-approved uses, formulations or treatment

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the

More information

Exploratory data: COPD and blood eosinophils. David Price: 9.23-9.35am

Exploratory data: COPD and blood eosinophils. David Price: 9.23-9.35am Exploratory data: COPD and blood eosinophils David Price: 9.23-9.35am Blood Eosinophilia in COPD The reliability and utility of blood eosinophils as a marker of disease burden, healthcare resource utilisation

More information

2.0 Synopsis. Vicodin CR (ABT-712) M05-765 Clinical Study Report R&D/07/095. (For National Authority Use Only) to Part of Dossier: Volume:

2.0 Synopsis. Vicodin CR (ABT-712) M05-765 Clinical Study Report R&D/07/095. (For National Authority Use Only) to Part of Dossier: Volume: 2.0 Synopsis Abbott Laboratories Name of Study Drug: Vicodin CR Name of Active Ingredient: Hydrocodone/Acetaminophen Extended Release (ABT-712) Individual Study Table Referring to Part of Dossier: Volume:

More information

A. Chronic inflammation from repeated exposure to noxious particles and gases

A. Chronic inflammation from repeated exposure to noxious particles and gases CHAPTER 15. CHRONIC OBSTRUCTIVE PULMONARY DISEASE SELF-ASSESSMENT QUESTIONS 1. All of the following play a role in the pathophysiology of COPD except: A. Chronic inflammation from repeated exposure to

More information

Journal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators

Journal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators Journal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators Shaikha Al Naimi Doctor of Pharmacy Student College of Pharmacy Qatar University

More information

SYNOPSIS (PAGE 1 OF 5)

SYNOPSIS (PAGE 1 OF 5) (PAGE 1 OF 5) Investigational Product: Naltrexone HCl 50 mg tablet and naltrexone HCl 1 mg solution Protocol No.: FEN-P01-102 CR003256 Title: Pharmacokinetics of Naltrexone Hydrochloride Following Intravenous

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

SYNOPSIS. 2-Year (0.5 DB + 1.5 OL) Addendum to Clinical Study Report

SYNOPSIS. 2-Year (0.5 DB + 1.5 OL) Addendum to Clinical Study Report Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Abatacept () Name of Active Ingredient: Abatacept () Individual Study Table Referring to the Dossier (For National Authority Use

More information

Control of COPD. PawełŚliwiński. Institute of Tuberculosis and Lung Diseases Warsaw, Poland

Control of COPD. PawełŚliwiński. Institute of Tuberculosis and Lung Diseases Warsaw, Poland Control of COPD PawełŚliwiński Institute of Tuberculosis and Lung Diseases Warsaw, Poland Elements of proper control Recognition Epidemiology Prevention Smoking cessation Early detection Education Physicians

More information

Sponsor Novartis. Generic Drug Name SBR759. Therapeutic Area of Trial. Chronic kidney disease (CKD) Approved Indication. Investigational.

Sponsor Novartis. Generic Drug Name SBR759. Therapeutic Area of Trial. Chronic kidney disease (CKD) Approved Indication. Investigational. Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Therapeutic Area of Trial Chronic kidney disease (CKD) Approved Indication Investigational Study Number CA2202 (12-month extension

More information

Predictors of Adherence to Inhaled Medications among Veterans with COPD. John Huetsch

Predictors of Adherence to Inhaled Medications among Veterans with COPD. John Huetsch Predictors of Adherence to Inhaled Medications among Veterans with COPD John Huetsch Background Medication nonadherence is a problem common to the treatment of many chronic diseases Potential obstacles

More information

Riociguat Clinical Trial Program

Riociguat Clinical Trial Program Riociguat Clinical Trial Program Riociguat (BAY 63-2521) is an oral agent being investigated as a new approach to treat chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain

PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain P a g e 1 PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain Clinical Phase 4 Study Centers Study Period 25 U.S. sites identified and reviewed by the Steering Committee and Contract

More information

SYNOPSIS. Final Clinical Study Report for Study CV Final Clinical Study Report

SYNOPSIS. Final Clinical Study Report for Study CV Final Clinical Study Report Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Individual Study Table Referring to the Dossier (For National Authority Use Only) Name of Active Ingredient: Saxagliptin SYNOPSIS

More information

Service Specification

Service Specification Service Specification Spirometry in Primary Care Date: February 2011 Document Reference: Service Specification (V4.0) Contents: Section Page 1 Definition of service 3 2 Training 4 3 Reporting / Monitoring

More information

Reslizumab for treating asthma with elevated blood eosinophils inadequately controlled by inhaled corticosteroids [ID872]

Reslizumab for treating asthma with elevated blood eosinophils inadequately controlled by inhaled corticosteroids [ID872] For public handouts Reslizumab for treating asthma with elevated blood eosinophils inadequately controlled by inhaled corticosteroids [ID872] 1 st Appraisal Committee meeting Clinical Effectiveness and

More information

NCT00272090. sanofi-aventis HOE901_3507. insulin glargine

NCT00272090. sanofi-aventis HOE901_3507. insulin glargine These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: Generic drug name:

More information

Phase: IV. Study Period: 20 Jan. 2006-17 Sep. 2008

Phase: IV. Study Period: 20 Jan. 2006-17 Sep. 2008 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Humulin (LY041001) Page 1 of 1

Humulin (LY041001) Page 1 of 1 (LY041001) These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or

More information

Role of dual bronchodilation in COPD

Role of dual bronchodilation in COPD Role of dual bronchodilation in COPD Canadian Respiratory Conference, Calgary, May 25 th, 2014 François Maltais Centre de Pneumologie IUCPQ Québec. Canada Disclosure Speaker bureau: Boehringer Ingelheim,

More information

Scottish Medicines Consortium. erdosteine 300mg capsules (Erdotin ) No. (415/07) Edmond Pharma Sr.l/Galen Ltd. 5 October 2007

Scottish Medicines Consortium. erdosteine 300mg capsules (Erdotin ) No. (415/07) Edmond Pharma Sr.l/Galen Ltd. 5 October 2007 Scottish Medicines Consortium erdosteine 300mg capsules (Erdotin ) No. (415/07) Edmond Pharma Sr.l/Galen Ltd. 5 October 2007 The Scottish Medicines Consortium has completed its assessment of the above

More information

Re: LUMIGAN 0.03% (bimatoprost ophthalmic solution 0.03%) and LUMIGAN 0.01% (bimatoprost ophthalmic solution 0.01%)

Re: LUMIGAN 0.03% (bimatoprost ophthalmic solution 0.03%) and LUMIGAN 0.01% (bimatoprost ophthalmic solution 0.01%) Allergan Ltd, 1st Floor, Marlow International, Parkway, Marlow, Bucks SL7 1YL Tel: (01628) 494444 Facsimile: (01628) 494449 Ref No: UK15-000677 Mandeep Allingham NW Surrey CCG February 18, 2015 Dear Ms

More information

1.0 Abstract. Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA. Keywords. Rationale and Background:

1.0 Abstract. Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA. Keywords. Rationale and Background: 1.0 Abstract Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA Keywords Rationale and Background: This abbreviated clinical study report is based on a clinical surveillance

More information

Clinical Trial Results Summary Study EN

Clinical Trial Results Summary Study EN Title of Study: A Phase 3, Open-label, Long-term Study to Evaluate the Safety, Tolerability, and Analgesic Efficacy of BEMA Buprenorphine in Subjects with Moderate to Severe Chronic Pain Requiring Continuous

More information

Confirming Diagnosis Through Spirometry

Confirming Diagnosis Through Spirometry Confirming Diagnosis Through Spirometry Shirley F. Jones, M.D., FCCP I have no conflicts of interest Instructional Objectives At the end of this session, learners will be able to: Select individual patients

More information

SYNOPSIS. Risperidone: Clinical Study Report CR003274

SYNOPSIS. Risperidone: Clinical Study Report CR003274 SYNOPSIS Protocol No: CR003274 Title of Study: An Open-Label, Long-Term Trial of Risperidone Long-Acting Microspheres in the Treatment of Subjects Diagnosed with Schizophrenia Coordinating Investigator:

More information

Longitudinal Modeling of Lung Function in Respiratory Drug Development

Longitudinal Modeling of Lung Function in Respiratory Drug Development Longitudinal Modeling of Lung Function in Respiratory Drug Development Fredrik Öhrn, PhD Senior Clinical Pharmacometrician Quantitative Clinical Pharmacology AstraZeneca R&D Mölndal, Sweden Outline A brief

More information

Arikace -Liposomal Amikacin: Preclinical Summary

Arikace -Liposomal Amikacin: Preclinical Summary Arikace -Liposomal Amikacin: Preclinical Summary Arikace is a sustained-release lipid formulation of amikacin for inhalation, being developed for lung infections due to susceptible pathogens Key Features

More information

Medical Policy An independent licensee of the Blue Cross Blue Shield Association

Medical Policy An independent licensee of the Blue Cross Blue Shield Association Afrezza Page 1 of 6 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: Afrezza (human insulin) Prime Therapeutics will review Prior Authorization requests Prior Authorization

More information

Prevention of Acute COPD exacerbations

Prevention of Acute COPD exacerbations December 3, 2015 Prevention of Acute COPD exacerbations George Pyrgos MD 1 Disclosures No funding received for this presentation I have previously conducted clinical trials with Boehringer Ingelheim. Principal

More information

Which smokers develop COPD? A prediction rule. Geijer RMM Sachs APE Verheij TJM Zuithoff, NPA Lammers J-WJ Hoes AW

Which smokers develop COPD? A prediction rule. Geijer RMM Sachs APE Verheij TJM Zuithoff, NPA Lammers J-WJ Hoes AW 5 Which smokers develop COPD? A prediction rule Geijer RMM Sachs APE Verheij TJM Zuithoff, NPA Lammers J-WJ Hoes AW 54 Prediction of moderate COPD Introduction Tobacco smoking is the main risk factor for

More information

Laboratorios Almirall, S.A. and Forest Laboratories, Inc. complete Phase III Studies in COPD

Laboratorios Almirall, S.A. and Forest Laboratories, Inc. complete Phase III Studies in COPD Laboratorios Almirall, S.A. and Forest Laboratories, Inc. complete Phase III Studies in COPD BARCELONA, July 7th: Laboratorios Almirall, S.A. and Forest Laboratories, Inc. (NYSE: FRX) have announced that

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

TUTORIAL on ICH E9 and Other Statistical Regulatory Guidance. Session 1: ICH E9 and E10. PSI Conference, May 2011

TUTORIAL on ICH E9 and Other Statistical Regulatory Guidance. Session 1: ICH E9 and E10. PSI Conference, May 2011 TUTORIAL on ICH E9 and Other Statistical Regulatory Guidance Session 1: PSI Conference, May 2011 Kerry Gordon, Quintiles 1 E9, and how to locate it 2 ICH E9 Statistical Principles for Clinical Trials (Issued

More information

ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes

ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes Effects of a fixed combination of the ACE inhibitor, perindopril,

More information

Version History. Previous Versions. Drugs for MS.Drug facts box fingolimod Version 1.0 Author

Version History. Previous Versions. Drugs for MS.Drug facts box fingolimod Version 1.0 Author Version History Policy Title Drugs for MS.Drug facts box fingolimod Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required

More information

FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C

FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C SR in Combination with an ERA and/or a PDE-5 Inhibitor

More information

FA 519 : Oxygen Administration for First Aid

FA 519 : Oxygen Administration for First Aid FA 519 : Oxygen Administration for First Aid TFQO: Wei-Tien Chang COI #301 EVREV 1: Michael Nemeth COI # EVREV 2: Chih-Hung Wang COI # Taskforce: First Aid COI Disclosure (specific to this systematic review)

More information

Statins patient decision aid

Statins patient decision aid Statins patient decision aid What this decision aid is for This decision aid is intended to assist health professionals in consultations with patients in whom treatment with a statin is being considered,

More information

Novel Trial Designs in T2D to Satisfy Regulatory Requirements for CV Safety

Novel Trial Designs in T2D to Satisfy Regulatory Requirements for CV Safety Novel Trial Designs in T2D to Satisfy Regulatory Requirements for CV Safety Anders Svensson MD, PhD Head of Global Clinical Development Metabolism, F Hoffmann LaRoche Ltd. Basel, Switzerland Overview of

More information

This supplementary material has been provided by the authors to give readers additional information about their work.

This supplementary material has been provided by the authors to give readers additional information about their work. SUPPLEMENTAL MATERIAL Table S1. The logistic regression model used to calculate the propensity score. Table S2. Distribution of propensity score among the treat and control groups of the full and matched

More information

Clinical Trial Results Summary Study EN

Clinical Trial Results Summary Study EN Study Number: EN3288-109 Title of Study: A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Crossover Study to Evaluate the Relative Bioavailability and Subjective Effects of EN3288 40

More information

Dr GH Kaye-Eddie Helen Joseph Hospital Pulmonology

Dr GH Kaye-Eddie Helen Joseph Hospital Pulmonology Dr GH Kaye-Eddie Helen Joseph Hospital Pulmonology Introduction Definitions Impact of Exacerbations Assessment of COPD Management of COPD Management of Acute Exacerbations Prevention of Exacerbations COPD

More information

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd.

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd. The Clinical Trial Protocol Guide 2011 BioStrategics Consulting Ltd. BioStrategics Consulting Ltd THE CLINICAL TRIAL PROTOCOL The clinical trial protocol to test one s product, to confirm or reject a specific

More information

What is meant by "randomization"? (Select the one best answer.)

What is meant by randomization? (Select the one best answer.) Preview: Post-class quiz 5 - Clinical Trials Question 1 What is meant by "randomization"? (Select the one best answer.) Question 2 A. Selection of subjects at random. B. Randomization is a method of allocating

More information

CLINICAL STUDY REPORT SYNOPSIS

CLINICAL STUDY REPORT SYNOPSIS CLINICAL STUDY REPORT SYNOPSIS Document No.: EDMS-PSDB-6511351:2.0 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Protocol No.: CR002353 Johnson & Johnson Pharmaceutical

More information

Medical management of CHF: A New Class of Medication. Al Timothy, M.D. Cardiovascular Institute of the South

Medical management of CHF: A New Class of Medication. Al Timothy, M.D. Cardiovascular Institute of the South Medical management of CHF: A New Class of Medication Al Timothy, M.D. Cardiovascular Institute of the South Disclosures Speakers Bureau for Amgen Background Chronic systolic congestive heart failure remains

More information

Chronic obstructive pulmonary disease. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study

Chronic obstructive pulmonary disease. Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study Eur Respir J 212; 4: 83 836 DOI: 1.1183/931936.225511 CopyrightßERS 212 Efficacy and safety of twice-daily aclidinium bromide in COPD patients: the ATTAIN study Paul W. Jones*, Dave Singh, Eric D. Bateman

More information

Chapter Five: Paired Samples Methods 1/38

Chapter Five: Paired Samples Methods 1/38 Chapter Five: Paired Samples Methods 1/38 5.1 Introduction 2/38 Introduction Paired data arise with some frequency in a variety of research contexts. Patients might have a particular type of laser surgery

More information

AKB-6548 clinical development overview early clinical studies (CI-0001 to CI-

AKB-6548 clinical development overview early clinical studies (CI-0001 to CI- AKB-6548 clinical development overview early clinical studies (CI-0001 to CI- 0004, and CI-0006) To date, AKB-6548 has been studied in 8 clinical trials across 4 separate patient populations: healthy volunteers

More information

Psoriasis, Incidence, Quality of Life, Psoriatic Arthritis, Prevalence

Psoriasis, Incidence, Quality of Life, Psoriatic Arthritis, Prevalence 1.0 Abstract Title Prevalence and Incidence of Articular Symptoms and Signs Related to Psoriatic Arthritis in Patients with Psoriasis Severe or Moderate with Adalimumab Treatment (TOGETHER). Keywords Psoriasis,

More information

COPD PROTOCOL CELLO. Leiden

COPD PROTOCOL CELLO. Leiden COPD PROTOCOL CELLO Leiden May 2011 1 Introduction This protocol includes an explanation of the clinical picture, diagnosis, objectives and medication of COPD. The Cello way of working can be viewed on

More information

Brief Communications. Awad Mohamed Ahmed, MD. Abstract

Brief Communications. Awad Mohamed Ahmed, MD. Abstract Awad Mohamed Ahmed, MD Professor of Medicine, University of Bahr Elghazal, Khartoum, Sudan For correspondence Professor Awad Mohamed Ahmed E-mail: awad.sd@gmail.com Tel.: +249 912344936 Abstract Randomized

More information

CLINICAL STUDY REPORT SYNOPSIS

CLINICAL STUDY REPORT SYNOPSIS CLINICAL STUDY REPORT SYNOPSIS Document No.: EDMS-PSDB-7762251:3.0 Name of Sponsor/Company Name of Finished Product INVEGA Name of Active Ingredient(s) Protocol No.: CR10858 Johnson & Johnson Pharmaceutical

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This file is posted on the Bayer HealthCare Clinical Trials Registry and Results website. It is provided for patients and healthcare professionals to increase the transparency of

More information

The Consequences of Missing Data in the ATLAS ACS 2-TIMI 51 Trial

The Consequences of Missing Data in the ATLAS ACS 2-TIMI 51 Trial The Consequences of Missing Data in the ATLAS ACS 2-TIMI 51 Trial In this white paper, we will explore the consequences of missing data in the ATLAS ACS 2-TIMI 51 Trial and consider if an alternative approach

More information

รศ.นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทย ศาสตร มหาว ทยาล ยขอนแก น

รศ.นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทย ศาสตร มหาว ทยาล ยขอนแก น รศ.นพ. ว ชรา บ ญสว สด M.D., Ph.D. ภาคว ชาอาย รศาสตร คณะแพทย ศาสตร มหาว ทยาล ยขอนแก น 1 COPD guideline Changing concept in COPD treatment COPD in practice 2 COPD Guidelines 3 Evidence-based Guidelines 4

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 27 July 2005 Doc. Ref. EMEA/CHMP/EWP/139391/2004 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) REFLECTION

More information

PATIENT GROUP DIRECTION (PGD) ADMINISTRATION OF INHALED SALBUTAMOL FOR THE EMERGENCY TREATMENT OF ACUTE ASTHMA OR COPD EXACERBATION AT HMP FORD

PATIENT GROUP DIRECTION (PGD) ADMINISTRATION OF INHALED SALBUTAMOL FOR THE EMERGENCY TREATMENT OF ACUTE ASTHMA OR COPD EXACERBATION AT HMP FORD PATIENT GROUP DIRECTION (PGD) ADMINISTRATION OF INHALED SALBUTAMOL FOR THE EMERGENCY TREATMENT OF ACUTE ASTHMA OR COPD EXACERBATION AT HMP FORD Version Number: 01HMP Patient Group Direction originally

More information

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POINTS TO CONSIDER ON MULTIPLICITY ISSUES IN CLINICAL TRIALS

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POINTS TO CONSIDER ON MULTIPLICITY ISSUES IN CLINICAL TRIALS The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 19 September 2002 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POINTS TO CONSIDER ON MULTIPLICITY

More information

Indacaterol (Onbrez)

Indacaterol (Onbrez) 1 for chronic obstructive pulmonary disease (IN-da-CAT-er-ol) A once-daily beta 2 -agonist for chronic obstructive pulmonary disease Key points Once-daily dosing provides symptomatic relief in COPD Indacaterol

More information

Global Strategy for the Diagnosis, Management and Prevention of COPD 2016 Clinical Practice Guideline. MedStar Health

Global Strategy for the Diagnosis, Management and Prevention of COPD 2016 Clinical Practice Guideline. MedStar Health Global Strategy f the Diagnosis, Management and Prevention of COPD 2016 Clinical Practice Guideline MedStar Health These guidelines are provided to assist physicians and other clinicians in making decisions

More information

Spirometry: Performance and Interpretation. A Guide for General Practitioners

Spirometry: Performance and Interpretation. A Guide for General Practitioners Irish Thoracic Society Spirometry: Performance and Interpretation A Guide for General Practitioners Dr. Terry O Connor, Consultant Respiratory Physician, Mercy University Hospital, Cork Dr. Pat Manning,

More information

Version History. Previous Versions. Drugs for MS.Drug facts box fampridine Version 1.0 Author

Version History. Previous Versions. Drugs for MS.Drug facts box fampridine Version 1.0 Author Version History Policy Title Drugs for MS.Drug facts box fampridine Version 1.0 Author West Midlands Commissioning Support Unit Publication Date Jan 2013 Review Date Supersedes/New (Further fields as required

More information

COPD RESOURCE PACK SECTION 2. Initiating a COPD Clinic: Protocol & Assessment

COPD RESOURCE PACK SECTION 2. Initiating a COPD Clinic: Protocol & Assessment COPD RESOURCE PACK SECTION 2 Initiating a COPD Clinic: Protocol & Assessment In this section: 1. Initiating a chronic disease management clinic 2. Equipment for a COPD clinic 3. Primary care chronic obstructive

More information

Analysis and Interpretation of Clinical Trials. How to conclude?

Analysis and Interpretation of Clinical Trials. How to conclude? www.eurordis.org Analysis and Interpretation of Clinical Trials How to conclude? Statistical Issues Dr Ferran Torres Unitat de Suport en Estadística i Metodología - USEM Statistics and Methodology Support

More information

Update in COPD. MeiLan Han, MD MS Associate Professor University of Michigan Division of Pulmonary and Critical Care

Update in COPD. MeiLan Han, MD MS Associate Professor University of Michigan Division of Pulmonary and Critical Care Update in COPD MeiLan Han, MD MS Associate Professor University of Michigan Division of Pulmonary and Critical Care Objectives Burden of disease: Understand the need for early recognition, prevention,

More information

New inhaled drugs for asthma & COPD: integration into UK practice

New inhaled drugs for asthma & COPD: integration into UK practice New inhaled drugs for asthma & COPD: integration into UK practice Hasanin Khachi Lead Pharmacist - Respiratory Medicine Joint Chair UKCPA Respiratory Group Barts Health NHS Trust 30 th September 2014 Outline

More information

Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes

Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes U.S. Department of Health and Human Services Food and Drug Administration Center

More information

Summary 1. Comparative-effectiveness

Summary 1. Comparative-effectiveness Cost-effectiveness of Delta-9-tetrahydrocannabinol/cannabidiol (Sativex ) as add-on treatment, for symptom improvement in patients with moderate to severe spasticity due to MS who have not responded adequately

More information

Statistics and Pharmacokinetics in Clinical Pharmacology Studies

Statistics and Pharmacokinetics in Clinical Pharmacology Studies Paper ST03 Statistics and Pharmacokinetics in Clinical Pharmacology Studies ABSTRACT Amy Newlands, GlaxoSmithKline, Greenford UK The aim of this presentation is to show how we use statistics and pharmacokinetics

More information

Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs

Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs Jay S. Skyler, MD, MACP Division of Endocrinology, Diabetes, and Metabolism and Diabetes Research Institute University of Miami Miller

More information

TEMPLATE DATA MANAGEMENT PLAN

TEMPLATE DATA MANAGEMENT PLAN TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager

More information

Drug: mepolizumab (Nucala) Class: Interleukin-5 Receptor Antagonist Line of Business: Non-Medicare Effective Date: February 17, 2016.

Drug: mepolizumab (Nucala) Class: Interleukin-5 Receptor Antagonist Line of Business: Non-Medicare Effective Date: February 17, 2016. This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics

More information

Week 12 study results

Week 12 study results Week 12 study results 15 April 2015 Copyright 2015 Galapagos NV Disclaimer This document may contain certain statements, including forward-looking statements, such as statements concerning the safety and

More information

2. Background This drug had not previously been considered by the PBAC.

2. Background This drug had not previously been considered by the PBAC. PUBLIC SUMMARY DOCUMENT Product: Ambrisentan, tablets, 5 mg and 10 mg, Volibris Sponsor: GlaxoSmithKline Australia Pty Ltd Date of PBAC Consideration: July 2009 1. Purpose of Application The submission

More information

GSK Medicine: Study Number: Title: Rationale: Study Period: Objectives Indication: Study Investigators/Centers: Research Methods Data Source:

GSK Medicine: Study Number: Title: Rationale: Study Period: Objectives Indication: Study Investigators/Centers: Research Methods Data Source: GSK Medicine: Study Number: 08257 Title: OCSIGEN study Longitudinal follow-up of a cohort of patients with asthma treated with inhaled corticosteroids in primary care Rationale: In the Post-Licensing File

More information

For personal use only

For personal use only ASX RELEASE 29 June 2011 QRxPharma Releases Additional Data on Phase 3 Comparative Safety Study for MoxDuo IR More comprehensive statistical analysis shows MoxDuo IR, at equi-analgesic doses to either

More information

A Phase 2 Study of Interferon Beta-1a (Avonex ) in Ulcerative Colitis

A Phase 2 Study of Interferon Beta-1a (Avonex ) in Ulcerative Colitis A Phase 2 Study of (Avonex ) in Ulcerative Colitis - Study Results - ClinicalTrials.gov A Phase 2 Study of (Avonex ) in Ulcerative Colitis This study has been completed. Sponsor: Biogen Idec Information

More information

Clinical Guideline. Recommendation 3: For stable COPD patients with respiratory symptoms

Clinical Guideline. Recommendation 3: For stable COPD patients with respiratory symptoms Clinical Guideline Diagnosis and Management of Stable Chronic Obstructive Pulmonary Disease: A Clinical Practice Guideline Update from the American College of Physicians, American College of Chest Physicians,

More information

Differentiating Asthma from COPD: Role of History, Physical Examination, Laboratory Studies, and Lung Function Testing

Differentiating Asthma from COPD: Role of History, Physical Examination, Laboratory Studies, and Lung Function Testing Differentiating Asthma from COPD: Role of History, Physical Examination, Laboratory Studies, and Lung Function Testing Stephen P Peters, MD, PhD, FAAAAI Professor of Medicine, Pediatrics and Translational

More information

2008 New Jersey Academy of Family Physicians

2008 New Jersey Academy of Family Physicians Chronic Obstructive Pulmonary Disease: Using Spirometry to Diagnose COPD in the Family Physician Office An evidence-based CME program developed by the New Jersey Academy of Family Physicians 2008 New Jersey

More information

Clinical Guideline. Recommendation 3: For stable COPD patients with respiratory symptoms

Clinical Guideline. Recommendation 3: For stable COPD patients with respiratory symptoms Clinical Guideline Diagnosis and Management of Stable Chronic Obstructive Pulmonary Disease: A Clinical Practice Guideline Update from the American College of Physicians, American College of Chest Physicians,

More information