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In February 2013, Glaxosmithkline (GSK) Announced a Commitment In February 2013, GlaxoSmithKline (GSK) announced a commitment to further clinical transparency through the public disclosure of GSK Clinical Study Reports (CSRs) on the GSK Clinical Study Register. The following guiding principles have been applied to the disclosure: Information will be excluded in order to protect the privacy of patients and all named persons associated with the study Patient data listings will be completely removed* to protect patient privacy. Anonymized data from each patient may be made available subject to an approved research proposal. For further information please see the Patient Level Data section of the GSK Clinical Study Register. Aggregate data will be included; with any direct reference to individual patients excluded *Complete removal of patient data listings may mean that page numbers are no longer consecutively numbered CONFIDENTIAL 2019N423508_00 The GlaxoSmithKline group of companies 201097 Division: Worldwide Development Information Type: Clinical Study Report Control: Usual Care Title: The effectiveness of Asthma Control Test guided treatment compared with usual care in China adult asthma patients Phase: IV Compound Number: CCI18781+GR33343 Effective Date: 8-JUN-2021 Subject: Asthma, Asthma Control Test guided Author(s): PPD Indication Studied: Asthma Initiation Date: 26-AUG-2016 Completion Date: 09-AUG-2019 Early Termination Date: NA Earlier CSRs NA Sponsor Signatory: Dr. Pauline Ng (and Medical Officer) Country Medical Director GlaxoSmithKline This study was performed in compliance with Good Clinical Practices and GlaxoSmithKline Standard Operating Procedures for all processes involved, including the archiving of essential documents. This study complies with US 21 CFR 312.120. Copyright 2021 the GlaxoSmithKline group of companies. All rights reserved. Unauthorised copying or use of this information is prohibited. CONFIDENTIAL 2019N423508_00 201097 Table of Contents Page TITLE PAGE .......................................................................................................... 1 ABBREVIATIONS .................................................................................................. 8 ETHICS AND GOOD CLINICAL PRACTICE ......................................................... 9 1. INTRODUCTION ................................................................................................ 10 2. STUDY OBJECTIVE(S) ..................................................................................... 10 2.1. Primary objective ............................................................................................. 10 2.2. Secondary objectives ....................................................................................... 10 2.3. Exploratory objective ....................................................................................... 10 3. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE .................. 10 4. INVESTIGATIONAL PLAN ................................................................................ 11 4.1. Study Design ................................................................................................... 11 4.2. Discussion of Study Design ............................................................................. 12 4.3. Protocol Amendment(s) ................................................................................... 12 4.4. Selection of Study Population .......................................................................... 12 4.4.1. Inclusion/Exclusion Criteria ......................................................................... 12 4.4.2. Withdrawal Criteria ...................................................................................... 13 4.5. Treatments ...................................................................................................... 13 4.5.1. Investigational Product(s) and Reference Therapy...................................... 13 4.5.2. Treatment Assignment ................................................................................ 13 4.5.3. Blinding ........................................................................................................ 14 4.5.4. Prior and Concomitant Medications and Non-Drug Therapies .................... 14 4.5.5. Compliance ................................................................................................. 14 4.6. Study Assessments and Procedures ............................................................... 14 4.6.1. Screening and Critical Baseline Assessments ............................................ 15 4.6.2. Efficacy Assessment ................................................................................... 16 4.6.3. Safety Assessments .................................................................................... 20 4.7. Data Quality Assurance ................................................................................... 21 4.8. Statistical Analyses .......................................................................................... 22 4.8.1. Statistical Hypotheses ................................................................................. 22 4.8.2. Sample Size Considerations ....................................................................... 22 4.8.3. Analysis Populations ................................................................................... 23 4.8.4. Interim Analyses .......................................................................................... 24 4.8.5. Final Analyses ............................................................................................. 24 4.8.6. Changes in Conduct of the Study or Planned Analyses .............................. 29 5. STUDY POPULATION RESULTS ..................................................................... 31 5.1. Subject Disposition .......................................................................................... 31 5.2. Protocol Deviations .......................................................................................... 32 5.3. Populations Analyzed ...................................................................................... 32 5.4. Demographics and Baseline Characteristics ................................................... 33 5.5. Past and Current Illness .................................................................................. 34 5.6. Asthma Medications ........................................................................................ 35 5.7. Concurrent Medications ................................................................................... 36 6. EFFICACY RESULTS ........................................................................................ 38 2 CONFIDENTIAL 2019N423508_00 201097 6.1. Primary Efficacy Results .................................................................................. 38 6.1.1. Percentage of Subjects Who Had an ACT Total Score ≥ 20 or an Improvement >3 Points in ACT Total Score in at Least One Post- baseline Assessment .............................................................................. 38 6.1.2. Percentage of Subjects Who Have an ACT Total Score ≥ 20 and an Improvement >3 Points in ACT Total Score ........................................... 43 6.1.3. Change from Baseline in ACT Total Score .................................................. 47 6.2. Secondary Efficacy Results ............................................................................. 48 6.2.1. Mean daytime symptom score over the 24-week treatment period ............. 48 6.2.2. Mean night-time symptom score over the 24-week treatment period .......... 49 6.2.3. Mean change from baseline to the end of study in FEV1 ............................ 50 6.2.4. Mean morning (AM) PEF over the 24-week treatment period ..................... 50 6.2.5. Mean evening (PM) PEF over the 24-week treatment period ...................... 51 6.2.6. Mean change from baseline to the end of study in AQLQ(S) score ............. 52 6.2.7. Time to first ACT total score ≥20 or an Improvement >3 Points in ACT total score over the 24-week treatment period ........................................ 52 6.2.8. Time to first ACT total score ≥20 and an Improvement >3 Points in ACT total score over the 24-week treatment period ........................................ 53 6.3. Exploratory Efficacy Results ............................................................................ 54 6.4. Other Post-hoc Efficacy Results ...................................................................... 56 6.4.1. Percentage of Subjects Who Had an ACT Total Score ≥ 20 or an Improvement ≥ 3 Points in ACT Total Score in at Least One Post- baseline Assessment .............................................................................. 56 6.4.2. Percentage of Subjects Who Had an ACT Total Score ≥ 20 and an Improvement ≥ 3 Points in ACT Total Score in at Least One Post- baseline Assessment .............................................................................. 56 6.4.3. Time to first ACT total score ≥20 or an Improvement ≥3 Points in ACT total score over the 24-week treatment period ........................................ 57 6.4.4. Time to first ACT total score ≥20 and an Improvement ≥3 Points in ACT total score over the 24-week treatment period ........................................ 58 6.5. Efficacy Conclusions........................................................................................ 58 7. SAFETY RESULTS ...........................................................................................
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