A Phase 3b Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Gefapixant in Adult Participants With Recent Onset Chronic Cough
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 91
- 主要终点
- Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration >8 weeks after onset of cough symptoms) for <12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chest radiograph or CT thorax (within 1 year of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease, in the opinion of the principal investigator or the subinvestigator
- •Has chronic cough (defined as duration of >8 weeks after onset of cough symptoms) for <12 months prior to the screening visit (<14 months after onset of cough symptoms)
- •Has a diagnosis of refractory chronic cough or unexplained chronic cough
- •Female participants are not pregnant, not breastfeeding, not of childbearing potential, or agree to follow contraceptive guidance
排除标准
- •Is a current smoker
- •Has given up smoking within 12 months of screening
- •Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)
- •Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening
- •Has a history of chronic bronchitis, defined as cough that produces >1 tablespoon of phlegm, that occurs every day for at least 3 months in a row
- •Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or cervical cancer
- •Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
- •Has a history of anaphylaxis or cutaneous adverse drug reaction to sulfonamide-containing drugs
- •Has a known allergy to gefapixant or its excipients
- •Has donated or lost ≥1 unit (~300 mL) of blood within 8 weeks prior to first dose of gefapixant
- •Has previously received gefapixant
- •Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study
研究组 & 干预措施
Gefapixant
Participants will receive gefapixant at a dose of 45 mg administered as an oral tablet twice daily for 12 weeks.
干预措施: Gefapixant (Drug)
Placebo
Participants will receive placebo matching gefapixant, administered as an oral tablet twice daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 12
时间窗: Baseline, Week 12
Participants will be asked to complete the LCQ to assess the impact of their cough severity on health related quality of life (HRQoL) over the past 2 weeks. The LCQ is a 19-item, cough-specific HRQoL questionnaire. Each item on the LCQ assesses symptoms using a 7-point scale ranging from 1 to 7. The LCQ contains three domains on physical, psychological, and social functioning, and each domain score is calculated as the mean score of the items (range: 1 to 7) within the domain. The LCQ total score is the sum of the 3 domains, with a range from 3 (lowest total score) to 21 (highest total score). Higher scores indicate better HRQoL. The change from baseline in LCQ total score is calculated.
次要结局
- Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score at Week 12(Baseline, Week 12)
- Percentage of Participants With One or More Adverse Events (AEs)(Up to approximately 14 weeks)
- Percentage of Participants Who Discontinue Study Drug Due to an AE(Up to approximately 12 weeks)