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Study Protocol 2016N289466_02 CONFIDENTIAL 2018N371775_00 GlaxoSmithKline group of companies 205832 TITLE PAGE Protocol Title: A Phase IIb, 24 week, randomized, double-blind, 3 arm parallel group study, comparing the efficacy, safety and tolerability of two doses of umeclidinium bromide administered once-daily via a dry powder inhaler, versus placebo, in participants with asthma Protocol Number:205832 / Amendment 2 Short Title: Short Title: A randomized, double-blind, parallel group study, comparing the efficacy, safety and tolerability of two doses of umeclidinium bromide administered once-daily via a dry powder inhaler, versus placebo, in participants with asthma Compound Number: GW685698+GSK573719 Sponsor Name and Legal Registered Address: GlaxoSmithKline Research & Development Limited 980 Great West Road Brentford Middlesex, TW8 9GS UK Medical Monitor Name and Contact Information can be found in the Study Reference Manual. Regulatory Agency Identifying Number(s): IND No. 104479, EudraCT number 2016- 002843-40 Approval Date: 06- JUL-2017 Copyright 2017 the GlaxoSmithKline group of companies. All rights reserved. Unauthorised copying or use of this information is prohibited. 1 2018N371775_00 PPD PPD PPD PPD 2016N289466_02 CONFIDENTIAL 2018N371775_00 205832 PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE DOCUMENT HISTORY Document Date Amendment 2: 2016N289466_02 06-Jul-2017 Amendment 1: 2016N289466_01 15-Nov-2016 Original Protocol: 2016N289466_00 19-Aug-2016 Amendment 2 06-July-2017 Overall Rationale for the Amendment: This protocol is being amended to: broaden the eligibility criteria of pre-bronchodilator FEV1 from ≤85% to ≤90% reflective of patients with non-obstructed asthma Allow re-screening of subjects, with advance approval by the medical monitor. Correct minor typographical errors and inconsistencies within the Schedule of Activities (SOA) and the protocol text. 3 2016N289466_02 CONFIDENTIAL 2018N371775_00 205832 Section # and Name Description of Change Brief Rationale Table of Contents: Update Section 7.1.3 to Update to include Section 7.1.3 include albuterol/salbutamol albuterol/salbutamol medication and be consistent medication for Return with the body of the protocol process Section 2: Schedule of Removed the Screen Run- Removed the Screen Run-in Activities (SOA) in “Window” day “-7d” Window day to avoid confusion. Section 2: Schedule of Added language to clarify To correct the inconsistency Activities (SOA) when ECG is to be between the Schedule of completed: ECG is to be Activities (SOA) and body of obtained after the vital the protocol signs assessment but prior to performing the pre- bronchodilator spirometry assessment (see Section 9.4.3). At all post randomization visits the ECG is to be obtained 15 minutes to 45 minutes after the administration of study treatment. Section 6.1: Inclusion Updating best pre- To allow the inclusion of Criteria; inclusion criteria bronchodilator morning asthma patients with slightly #5 (AM) FEV1 to ≤90% less restricted lung function. Lung function does not always correlate with asthma severity Section 6.2.2: Inclusion Updating Spirometry: best To allow the inclusion of Criteria for pre-bronchodilator asthma patients with slightly Randomization; inclusion morning (AM) FEV1 to less restricted lung function. criteria #2 ≤90% Lung function does not always correlate with asthma severity. Section 6.4 Pre- Update to Include re- To allow the re-screening of Screening/Screening/Run- screening language: Re- subjects, with advance medical In/Randomization screening of subjects will monitor approval Failures be permitted; however, advance written approval to proceed with re- screening a subject must be obtained from the Medical Monitor 4 2016N289466_02 CONFIDENTIAL 2018N371775_00 205832 Section # and Name Description of Change Brief Rationale Section 7.1.3: Study Update to include Update to include Treatment, specifically the medication albuterol/salbutamol albuterol/salbutamol, and name, albuterol/salbutamol medication and be consistent FF 100 mcg., Return to the return process with the body of the protocol Section 9.1.4: Asthma Added “moderate” to the Added “moderate” to be Exacerbation last sentence in the consistent with other sections paragraph of the protocol and to clearly state that both moderate and severe exacerbations are to be captured in the eCRF Section 9.4.3: Added language (“but prior Added (“but prior to Electorcardiograms to performing pre- performing pre-bronchodilator bronchodilator spirometry spirometry assessment”) to assessment”) to clarify clearly explain that the ECG is when the ECG is to be to be performed after vitals but done. prior to spirometry. The specific time points for performing ECGs are clarified in the SOA 5 2016N289466_02 CONFIDENTIAL 2018N371775_00 205832 TABLE OF CONTENTS PAGE PROTOCOL AMENDMENT SUMMARY OF CHANGES TABLE.....................................3 1. SYNOPSIS...............................................................................................................9 2. SCHEDULE OF ACTIVITIES (SOA).......................................................................13 3. INTRODUCTION....................................................................................................19 3.1. Study Rationale ..........................................................................................19 3.2. Background ................................................................................................19 3.3. Benefit/Risk Assessment ............................................................................19 3.3.1. Risk Assessment .........................................................................20 3.3.2. Benefit Assessment .....................................................................26 3.3.3. Overall Benefit: Risk Conclusion..................................................26 4. OBJECTIVES AND ENDPOINTS...........................................................................26 5. STUDY DESIGN ....................................................................................................28 5.1. Overall Design ............................................................................................28 5.2. Number of Participants ...............................................................................30 5.3. Participant and Study Completion...............................................................30 5.4. Scientific Rationale for Study Design ..........................................................30 5.5. Dose Justification........................................................................................31 6. STUDY POPULATION ...........................................................................................31 6.1. Inclusion Criteria.........................................................................................31 6.2. Exclusion Criteria........................................................................................33 6.2.1. Randomization Criteria ................................................................35 6.2.2. Inclusion Criteria for Randomization ............................................35 6.2.3. Exclusion Criteria for Randomization ...........................................36 6.3. Lifestyle Restrictions...................................................................................36 6.4. Pre-Screening/Screening/Run-in/Randomization Failures ..........................36 7. TREATMENTS.......................................................................................................37 7.1. Treatments Administered............................................................................37 7.1.1. Description of FF 100 mcg and Double-Blind Study Treatment ....................................................................................37 7.1.2. Description of Albuterol/Salbutamol .............................................39 7.1.3. Study Treatment, albuterol/salbutamol, and FF 100 mcg Return..........................................................................................39 7.2. Dose Modification .......................................................................................39 7.3. Method of Treatment Assignment ...............................................................39 7.4. Blinding.......................................................................................................40 7.5. Packaging and Labeling..............................................................................41 7.6. Preparation/Handling/Storage/Accountability ..............................................41 7.7. Treatment Compliance................................................................................41 7.8. Concomitant Therapy..................................................................................42 7.8.1. Permitted Medications and Non-Drug Therapies..........................42 7.8.1.1. Permitted Asthma Medications ...................................42 7.8.1.2. Permitted Non-Asthma Medications ...........................43 6 2016N289466_02 CONFIDENTIAL 2018N371775_00 205832 7.9. Prohibited Medications and Non-Drug Therapies........................................44 7.10. Treatment after the End of the Study ..........................................................45 8. DISCONTINUATION CRITERIA.............................................................................45 8.1. Discontinuation of Study Treatment ............................................................45 8.1.1. Liver Chemistry Stopping Criteria ................................................46
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