Clinical Research Pediatric Pulmonary Division

Transcription

1 Clinical Research Pediatric Pulmonary Division Hengameh H. Raissy, PharmD Research Associate Professor, Pediatric Pulmonary UNM HSC Director of Clinical Trials Presented at Envision NM Asthma / Pulmonary Telehealth Session October 9, 2013 Thank you for attending this Envision NM webinar conference. We will begin shortly. NEW To connect audio, please telephone (no access code needed) Please mute/un mute your telephone line by pressing *#. You may also press your mute button on your headset or speakerphone during the webinar when you are not speaking. Do not place your phone on hold. If you wish to receive CME/CEU/ or an attendance certificate, you must announce your name when we ask who is participating both at the start and at the end of the session. Your certificate will be ed to you after the end of this calendar quarter. If you are called on and do not wish to answer, feel free to say pass. 10/9/

2 Disclosure: UNM CME policy, in compliance with the ACCME Standards of Commercial Support, requires that anyone who is in a position to control the content of an activity disclose all relevant financial relationships they have had within the last 12 months with a commercial interest related to the content of this activity. The presenter, Hengameh Raissy, Pharm.D, is the Co-author of the discussed articles and the principal investigator of CAMP, CARE and AsthmaNet trials (Funded by NHLBI) Accreditation: The University of New Mexico School of Medicine, Office of Continuing Medical Education is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Office of Continuing Medical Education designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s). Physicians should only claim credit commensurate with the extent of their participation in the activity. Envision NM is a division of the UNM Department of Pediatrics and receives funding from the NM Department of Health and the NM Human Services Department. 10/9/ Molina Health Care partners with Envision New Mexico! Molina Healthcare is offering payment to NM primary care providers who seek specialty consultation for their Molina patients through Envision New Mexico Telehealth In addition, on behalf of the primary care provider, non physician providers (eg. RN, PA, NP, RD, LMSW, LISW) involved with a Molina patient s care may present cases to an ENM Telehealth clinic and your practice will receive the reimbursement. Enter code Q3014 with GT modifier on a standard Medicaid claim form and receive a $150 reimbursement for the presentation of Molina member cases to one of the above Envision New Mexico Telehealth clinics. Eligible clinics are: Childhood Overweight Medical Management Telehealth Clinic (COMM TC) Pediatric Nutrition Telehealth Clinic (PNT) Telepsychiatry: Pediatric Integrated Case Conference (T:PICC) Telepsychiatry Consultation for Pediatric and School Base Health Clinic Providers Asthma/Pulmonary Telehealth Clinic (APT) For the specifics on how to request your Specialty Consultation, please contact: Clancey Tarbox, Envision New Mexico Program Coordinator, ctarbox@salud.unm.edu For more information about the reimbursement, please contact: Michel Faust, Care Coordinator, Molina Healthcare of New Mexico Direct Line: Toll Free: Ext Fax: Michel.Faust@MolinaHealthCare.Com Molina also offers a Healthy Incentives Program including health services for diabetes, asthma, mammograms, yearly Pap Exams, well child checkups and more. See the Molina website for more information: 10/9/

3 Rollcall If you wish to receive CME/CEU/ or an attendance certificate, please tell us your name. Please un mute your telephone line by pressing *#. 10/9/ Clinical Research Pediatric Pulmonary Division Hengameh H. Raissy, PharmD Research Associate Professor, Pediatric Pulmonary UNM HSC Director of Clinical Trials 3

4 Clinical & Translational Research Center (CTSC) To improve human health Translation of scientific discoveries into practical applications 10/9/

5 CAMP Trial Treatments Randomization to: Budesonide 200 mcg by Turbuhaler bid Nedocromil 8 mg by MDI bid Placebo Rescue protocol: Albuterol as needed Prednisone, for exacerbations 5 mg/kg up to 60 mg for 2 days 2.5 mg/kg up to 30 mg for 2 more days 10/9/ CAMP Trial and Follow up Design Routine Care Screening and Baseline 5 visits Treatment Trial 3 visits per year Transitio n 2 visits Followup 1-4 visits per year 2-4 months Randomize Budesonide Nedocromil Placebo 4 6 years 4 months Study Rx Discontinued 13 years Enroll in follow-up study Refer back to PCP for Rx per NAEPP guidelines Enrollment in trial: Dec 1993 Sept ,041 children age 5-13 years at randomization Mild to moderate persistent asthma 10 5

6 CAMP STUDY: Results N Engl J Med 2000;343: Subjects randomized to budesonide (BUD) compared to placebo had Decreased airway hyperresponsiveness (P<0.001) 43% fewer hospitalizations (P<0.04) 45% fewer urgent care visits (P<0.001) 43% less prednisone use (P<0.001) Less rescue albuterol use (P<0.001) Fewer symptoms (P=0.005) More episode-free days (P=0.01) 10/9/ NAEPP Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma The ICS are more effective than other agents on all asthma outcome measures. ICSs are preferred treatment for all aged patients with persistent asthma Alternatives (listed alphabetically) include cromolyn, leukotriene receptor antagonists, nedocromil, and sustained release theophylline 10/9/

7 CAMP Trial and Follow up Design Routine Care Screening and Baseline 5 visits Treatment Trial 3 visits per year Transitio n 2 visits Followup 1-4 visits per year 2-4 months Randomize Budesonide Nedocromil Placebo 4 6 years 4 months Study Rx Discontinued 13 years Enroll in follow-up study Refer back to PCP for Rx per NAEPP guidelines Enrollment in trial: Dec 1993 Sept ,041 children age 5-13 years at randomization 10/9/2013 Mild to moderate persistent asthma 13 Mean Obtained Adjusted Adult Height 10/9/

8 Asthma Networks Childhood Asthma Research and Education (CARE) Network 5 centers: 1999, 2004 Clinical Centers University of New Mexico Albuquerque, NM National Jewish Medical & Research Center Denver, CO University of Wisconsin Madison, WI Center for Urban Population Health Milwaukee, WI University of California (Kaiser Permanente) San Diego, CA Washington University, St. Louis, MO University of Arizona Tucson, AZ AsthmaNet ( ) AsthmaNet is a nationwide clinical research network created by the National Heart Lung and Blood Institute (NHLBI) in The purpose of AsthmaNet is to develop and conduct multiple clinical trials that explore new approaches in treating asthma from childhood through adulthood. AsthmaNet studies are being conducted in 13 states. Pediatric clinical centers: Albuquerque, NM Atlanta, GA Boston, MA Charlottesville, VA Chicago, IL Cleveland, OH Denver, CO Madison, WI Milwaukee, WI Oakland, CA Pittsburgh, PA Raleigh, NC St. Louis, MO San Francisco, CA Tucson, AZ Winston-Salem, NC 10/9/ Cohort: ages 6-17 years old with mild asthma TReating Children to Prevent EXacerbations of Asthma (TREXA) Run-in to demonstrate control on low dose ICS 10/9/

9 Results for the Primary Outcome: Comparisons with the Placebo Arm Lancet 2011; 377: /9/ Treatment Failures (Two Exacerbations in 6 months) Combined arm: 5.6%* Daily arm: 2.8%* Rescue arm: 8.5%* Placebo arm: 23.0% *p<0.05 compared to placebo 10/9/

10 Linear Growth From Randomization to End of Trial Conclusions Discontinuing ICS causes an unacceptable increase in exacerbations in children with well-controlled, mild persistent asthma Daily ICS is the most effective treatment for preventing exacerbations; adding rescue ICS does not add benefit Rescue ICS with albuterol demonstrates benefits over albuterol alone and avoids daily ICS administration and its growth effects 10/9/

11 Maintenance vs Intermittent Inhaled Steroids In Wheezing Toddlers (MIST) 10/9/ Result of MIST N Engl J Med 2011;365: A daily low-dose regimen of budesonide was not superior to an intermittent high dose regimen in reducing asthma exacerbations. Daily administration led to greater exposure to the drug at 1 year. 10/9/

12 APRIL - Azithromycin for Preventing the development of upper Respiratory tract Illness into Lower respiratory tract symptoms in children APRIL - Azithromycin for Preventing the development of upper Respiratory tract Illness into Lower respiratory tract symptoms in children 10/9/ INFANT - Individualized Therapy For Asthma in Toddlers N=294 10/9/

13 Rollcall If you wish to receive CME/CEU/ or an attendance certificate, please tell us your name. Please un mute your telephone line by pressing *#. 10/9/ Thank You! 10/9/