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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.

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3 Page 2 of 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. Actual (cont.): Table 1: Patients treated and analysed (primary endpoint) Treated Analysed Tio+Olo FDC (5/5 µg) Tio (5 µg)/olo (5 μg) free combination Placebo Diagnosis: Patients with COPD Main Criteria for Inclusion: Outpatients with COPD 40 years old, smoking history of >10 pack years, postbronchodilator forced expiratory volume in 1 second (FEV1) 30% and <80% of predicted normal, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II III, and post-bronchodilator FEV1/ forced vital capacity (FVC) <70%. BI Investigational Product: Tio+Olo FDC inhalation solution - RESPIMAT Dose: 5 μg tiotropium / 5 μg olodaterol (2.5 μg each per actuation) Mode of Admin.: Oral inhalation Batch No.: B and B Comparator Product: Olodaterol inhalation solution - RESPIMAT Dose: 5 µg (2.5 μg per actuation) Mode of Admin.: Oral inhalation Batch No.: B and B

4 Page 3 of 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.: Tiotropium inhalation solution RESPIMAT 5 µg (2.5 μg per actuation) Oral inhalation B and B Comparator Product: Dose Mode of Admin.: Batch No.: Placebo inhalation solution RESPIMAT Oral inhalation B and B Duration of Treatment: 3 treatment visits with single doses, separated by 3-week washout periods Criteria for Evaluation: Primary endpoint: FEV1 AUC0-3h response (area under the curve from 0 to 3 h Efficacy: post-inhalation divided by 3) (change from patient baseline) Further endpoints: FVC AUC0-3h response FEV1 peak0-3h response FVC peak0-3h response FEV1 at 15 and 30 min, and at 1, 2, and 3 h after inhalation of study medication FVC at 15 and 30 min, and at 1, 2, and 3 h after inhalation of study medication Safety: Secondary endpoints - Holter resting ECG parameters (analysed over all post-dose time points of 5, 10, 25, and 50 min after inhalation): Mean and peak QTcF interval change from patient baseline Mean and peak heart rate change from patient baseline Other secondary endpoints - Holter resting ECG parameters Mean and peak RR, QT, QTcB, PR and QRS interval change from patient baseline analysed over all post-dose time points (5, 10, 25, and 50 min) RR, QTcF, QTcB, PR, and QRS intervals and heart rate at individual postdose time points (5, 10, 25, and 50 min)

5 Page 4 of 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. Safety (cont.): Statistical Methods: Other secondary endpoints - categorical ECG endpoints: New onset of any QTcF interval >450 ms, >480 ms or >500 ms Occurrence of increase from baseline of QTcF interval >30 to 60 ms or >60 ms The occurrence of any of the following at any time post-treatment was to be regarded as notable findings: New onset of uncorrected QT interval >500 ms New onset of QTcF > 500 ms Occurrence of increase from baseline of QTcF interval >60 ms Increase of heart rate by 25% from baseline, when corresponding ontreatment value of heart rate was >100 bpm or decrease of heart rate by 25%, when corresponding on-treatment value of heart rate was <50 bpm Increase of the PR interval from baseline by 25%, when corresponding on-treatment value of PR interval was >200 ms Increase of the QRS complex from baseline by 10%, when corresponding on-treatment value of QRS complex was >110 ms Routine safety monitoring based on adverse events (AEs), pulse rate and blood pressure at trial start and end of treatment (EOT) and pre-dose and post-dose on Visits 2 to 4, physical examination at trial start and EOT, and standard 12-lead ECG at the screening visit and EOT Visit. Analysis of all efficacy endpoints was based on the full analysis set (FAS), which included all patients in the treated set (TS) who had at least 1 visit (Visit 2, 3, or 4) with both the period baseline value plus any evaluable post-dose spirometry measurement available from the same visit. As there were 2 different active treatment arms, the following hypotheses were tested in hierarchical order for the primary endpoint, each at the 5% level of significance (2-sided) to protect the overall probability of type I error at 0.05 (2-sided): first a treatment comparison of Tio+Olo FDC with placebo, followed by a treatment comparison of Tio/Olo free combination with placebo. In the primary analysis, the ordered hypotheses were tested based on the adjusted mean FEV1 AUC0-3h response using a restricted maximum likelihood (REML)based mixed effect model repeated measures (MMRM) approach.

6 Page 5 of 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. Statistical Methods (cont.): The model included treatment and period as fixed effects, patient as random effect, and period baseline value and patient baseline value as covariates. Compound symmetry was used as a covariance structure for within-patient variation. The Kenward-Roger method was used to estimate the denominator degrees of freedom. Adjusted mean values and treatment differences were calculated together with the 95% confidence interval (CI) and p-value. In addition, the primary endpoint was summarised by treatment arm using descriptive statistics. The secondary safety endpoints and other secondary safety endpoints were analysed using the treated set. Safety analyses were descriptive. No formal hypothesis test was planned. The MMRM described for the primary endpoint was also used for the further efficacy endpoints and for the individual pre- and post-treatment time points (-1 h, -10 min, 15 min, 30 min, 1 h, 2 h, and 3 h). Adjusted mean values as well as treatment contrasts were presented together with the 95% CIs and nominal p-values. All treatment comparisons for the further endpoints were considered as descriptive. In addition, the further efficacy endpoints were summarised by treatment arm using descriptive statistics. SUMMARY - CONCLUSIONS: Trial Subjects and Compliance with Trial Protocol: Fifty-three (53) patients were randomised and 52 (98.1%) completed the trial. One patient prematurely discontinued study medication because of the trial disease worsening. There were no important protocol violations. At baseline, the patients mean age was 64.4 years (range 50 to 76 years); 31 (58.5%) patients were male, 22 (41.5%) patients were female, and 52 (98.1%) patients were White. All patients were either former smokers (60.4%) or current smokers (39.6%) with a mean smoking history of 56.2 pack-years (range 16 to 183 pack-years). The mean body mass index was 26.5 kg/m2. Efficacy Results: Primary endpoint For the primary endpoint (FEV1 AUC0-3h response [L] after single-dose administration), both active treatments were superior to placebo. Adjusted mean FEV1 AUC0-3h response (standard error [SE]) was (0.016) L for placebo, (0.016) L for Tio+Olo FDC, and (0.016) L for Tio/Olo free

7 Page 6 of 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. Efficacy Results (cont.): combination. Improvement (95% CI) of Tio+Olo FDC over placebo was L (0.187 L, L) and improvement of Tio/Olo free combination over placebo was L (0.220 L, L). The type I error was protected only for the above 2 comparisons. All other comparisons and analyses of further endpoints were not included in the hierarchical testing sequence and were therefore considered descriptive (nominal p-values and 95% CI). The treatment difference (95% CI) in adjusted mean FEV1 AUC0-3h response between Tio+Olo FDC and Tio/Olo free combination was ( L, L). Further endpoints The increases (95% CI) in FEV1 peak0-3h response of Tio+Olo FDC and Tio/Olo free combination compared with placebo were L (0.200 L, L) and L (0.232 L, L), respectively. The treatment difference (95% CI) in adjusted mean FEV1 peak0-3h response between Tio+Olo FDC and Tio/Olo free combination was L ( L, L). Both active treatments yielded similar 3-h profiles and showed increases over placebo in adjusted mean FEV1 at all post-dose time points, ranging from to L. Both Tio+Olo FDC and Tio/Olo free combination showed improvement over placebo in FVC AUC0-3h response, with treatment differences (95%CI) of L (0.218 L, L) and L (0.273 L, L), respectively. The treatment difference (95% CI) in adjusted mean FVC AUC0-3h response between Tio+Olo FDC and Tio/Olo free combination was L ( L, L). The increases (95% CI) in FVC peak0-3h response of Tio+Olo FDC and Tio/Olo free combination compared with placebo were L (0.236 L, L) and L (0.264 L, L), respectively. The treatment difference (95% CI) in adjusted mean FVC peak0-3h response between Tio+Olo FDC and Tio/Olo free combination was L ( L, L). Both active treatments yielded similar 3-h profiles and showed increases over placebo in adjusted mean FVC of to L at all post-dose time points. Safety Results: In this single-dose cross-over trial with 3 treatments in 3 periods, study medication was generally well tolerated. Adverse events were reported in a total of 43.4% of patients; a higher proportion of patients reported AEs in the placebo arm compared with patients in the Tio+Olo FDC and Tio/Olo free combination

8 Page 7 of 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. Safety Results (cont.): arms (32.1% compared to 9.6% and 13.5%, respectively). Of note, AEs were assigned to a given treatment period if they started after the first intake and ended within 21 days after the last intake of study medication for that period. Most frequently, AEs were reported in the SOC infections and infestations ([10] 18.9% of patients overall). The most frequent AEs were nasopharyngitis, COPD worsening (coded as COPD), bronchitis, and toothache. Overall, nasopharyngitis was reported in 5 (9.4%) patients (placebo: 3 patients; Tio+Olo FDC: 1 patient, Tio/Olo free combination: 2 patients), COPD worsening in 3 (5.7%) patients (1 patient in each treatment arm), and bronchitis in 2 (3.8%) patients (placebo: 1 patient; Tio+Olo FDC: none, Tio/Olo free combination: 1 patient); toothache was reported by 2 (3.8%) patients in the placebo group and for none of the patients in the Tio+Olo FDC and Tio/Olo free combination arm. There was 1 patient with an AE leading to discontinuation (COPD, in the placebo arm). None of the AEs were considered related to study medication by the investigator. Nearly all AEs were mild or moderate in intensity, only 1 patient in the Tio/Olo free combination arm had a severe AE (prinzmetal angina). There were 2 patients with non-fatal SAEs (prinzmetal angina and cystocele, both in the Tio/Olo free combination arm), and no deaths. There were no notable differences between the treatment arms in vital signs. Mean QTcF interval change from patient baseline over all post-dose time points (i.e. 5, 10, 25, and 50 min after inhalation of study medication) was 1.3 ms for placebo, 2.2 ms for Tio+Olo FDC, and 1.9 ms for Tio/Olo free combination. Peak QTcF interval change from patient baseline over all post-dose time points was 5.2 ms for placebo and 5.7 ms for both active treatments. Changes from baseline for QT and QTcB were comparable for all treatments. For QTcF, there was 1 patient with a new onset of a QTcF interval exceeding 500 ms at some time points during all 3 treatments with no time- or treatment-related pattern. No imbalances between the treatment arms were observed and no patient in any treatment arm had an absolute change from baseline in QTcF interval that exceeded 30 ms at any post-dose time point. There was no patient with a new onset of an uncorrected QT interval exceeding 500 ms anytime post-treatment. Mean heart rate change from patient baseline over all post-dose time points was -3.0 beats per minute (bpm) for placebo, -2.5 bpm for Tio+Olo FDC, and -3.6 bpm for Tio/Olo free combination. Peak heart rate change from patient

9 Page 8 of 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. baseline over all post-dose time points was -0.7 bpm after treatment with placebo and -0.3 bpm and -1.2 bpm for Tio+Olo FDC and Tio/Olo free combination, respectively. No patients exceeded any of the pre-specified heart rate thresholds at any post-dose time point. There were no clinically meaningful differences for changes from baseline in RR interval, PR interval, and QRS complex between the treatment arms and no time-related patterns were observed. Conclusions: For the primary endpoint (FEV1 AUC0-3h response after single-dose administration), both Tio+Olo FDC and Tio/Olo free combination were superior to placebo, and analyses for all further efficacy endpoints based on FEV1 and FVC supported the results of the primary endpoint. Both Tio+Olo FDC and Tio/Olo free combination were well tolerated; no safety concerns were identified in the trial. Of note, no adverse effects on QT/QTcF intervals or heart rate were observed.

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

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