NCT02612610已完成2 期
A 12-Week Study to Assess the Efficacy and Safety of AF 219 in Subjects With Refractory Chronic Cough
Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)0 个研究点目标入组 253 人开始时间: 2015年12月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 主要终点
- Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84)
研究概览
简要总结
This study is designed to evaluate the efficacy of three dose regimens of gefapixant ([MK-7264] 7.5 mg, 20 mg, and 50 mg) relative to placebo in reducing awake objective cough frequency. The primary hypothesis for this trial is that at least one dose regimen of gefapixant is superior to placebo with respect to the mean change from baseline in awake cough frequency (on the log scale).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and Men between 18 and 80 years of age inclusive
- •Have refractory chronic cough
- •Women of child-bearing potential must use 2 forms of acceptable birth control - Have provided written informed consent.
- •Are willing and able to comply with all aspects of the protocol
排除标准
- •Current smoker
- •Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ratio <60%
- •History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
- •History of opioid use within 1 week of the Baseline Visit
- •Body mass index (BMI) <18 kg/m^2 or ≥ 40 kg/m^2
- •History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including subjects with <3 excised basal cell carcinomas)
- •Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
- •Clinically significant abnormal electrocardiogram (ECG) at Screening
- •Significantly abnormal laboratory tests at Screening
- •Pregnant or Breastfeeding
- •Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participant inappropriate for entry into this trial
研究组 & 干预措施
Placebo
Placebo Comparator
Participants received one matching placebo tablet administered by mouth twice daily for 12 weeks.
干预措施: Placebo (for gefapixant) (Drug)
Gefapixant 7.5 mg
Experimental
Participants received one 7.5 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
干预措施: Gefapixant (Drug)
Gefapixant 20 mg
Experimental
Participants received one 20 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
干预措施: Gefapixant (Drug)
Gefapixant 50 mg
Experimental
Participants received one 50 mg gefapixant tablet administered by mouth twice daily for 12 weeks.
干预措施: Gefapixant (Drug)
结局指标
主要结局
Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84)
时间窗: Baseline Visit (Day -1), Day 84
Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. Least-squares (LS) mean change from baseline (in log scale) with associated standard error (SE) reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).
次要结局
- Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84)(Baseline (Study Day -1), Day 84)
- Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28)(Baseline (Study Day -1), Day 28)
- Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56)(Baseline (Study Day -1), Day 56)
- Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28)(Baseline (Study Day -1), Day 28,)
- Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56)(Baseline (Study Day -1), Day 56)
- Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After 4 Weeks of Treatment (Day 28)(Baseline (Study Day -1), Day 28)
- Change From Baseline in Cough Severity VAS After 12 Weeks of Treatment (Day 84)(Baseline (Study Day -1), Day 84)
- Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28)(Baseline (Study Day -1), Day 28)
- Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84)(Baseline (Study Day -1), Day 84)
- Change From Baseline in Weekly Mean Daily CSD Total Score at Week 11(Baseline, Week 11)
- Change From Baseline in Weekly Mean Daily CSD Total Score at Week 12(Baseline, Week 12)
- Change From Baseline in Weekly Mean DCS at Week 2(Baseline, Week 2)
- Change From Baseline in Cough Severity VAS After 8 Weeks of Treatment (Day 56)(Baseline (Study Day -1), Day 56)
- Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98)(Baseline (Study Day -1), Day 98)
- Change From Baseline in Weekly Mean Daily CSD Total Score at Week 5(Baseline, Week 5)
- Change From Baseline in Weekly Mean Daily CSD Total Score at Week 6(Baseline, Week 6)
- Change From Baseline in Weekly Mean Daily CSD Total Score at Week 8(Baseline, Week 8)
- Change From Baseline in Weekly Mean Daily Cough Score (DCS) at Week 1(Baseline, Week 1)
- Change From Baseline in Weekly Mean DCS at Week 4(Baseline, Week 4)
- Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98)(Baseline (Study Day -1), Day 98)
- Change From Baseline in Cough Severity VAS At Day 85/Early Termination(Baseline (Study Day -1), Day 85)
- Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56)(Baseline (Study Day -1), Day 56)
- Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84)(Baseline (Study Day -1), Day 84)
- Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98)(Baseline (Study Day -1), Day 98)
- Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28)(Baseline (Study Day -1), Day 28)
- Change From Baseline in Sleep Objective Cough Frequency After 8 Weeks of Treatment (Day 56)(Baseline (Study Day -1), Day 56)
- Change From Baseline in Weekly Mean Daily Cough Severity Diary (CSD) Total Score at Week 1(Baseline, Week 1)
- Change From Baseline in Weekly Mean Daily CSD Total Score at Week 2(Baseline, Week 2)
- Change From Baseline in Weekly Mean Daily CSD Total Score at Week 3(Baseline, Week 3)
- Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56)(Baseline (Study Day -1), Day 56)
- Change From Baseline in Sleep Objective Cough Frequency After 4 Weeks of Treatment (Day 28)(Baseline (Study Day -1), Day 28)
- Change From Baseline in Sleep Objective Cough Frequency After 12 Weeks of Treatment (Day 84)(Baseline (Study Day -1), Day 84)
- Change From Baseline in Weekly Mean Daily CSD Total Score at Week 4(Baseline, Week 4)
- Change From Baseline in Weekly Mean Daily CSD Total Score at Week 7(Baseline, Week 7)
- Change From Baseline in Weekly Mean Daily CSD Total Score at Week 9(Baseline, Week 9)
- Change From Baseline in Weekly Mean Daily CSD Total Score at Week 10(Baseline, Week 10)
- Change From Baseline in Weekly Mean DCS at Week 7(Baseline, Week 7)
- Change From Baseline in Weekly Mean DCS at Week 9(Baseline, Week 9)
- Change From Baseline in Weekly Mean DCS at Week 12(Baseline, Week 12)
- Change From Baseline in Weekly Mean DCS at Week 3(Baseline, Week 3)
- Change From Baseline in Weekly Mean DCS at Week 6(Baseline, Week 6)
- Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 4 Weeks of Treatment (Day 28)(Baseline, Day 28)
- Change From Baseline in Weekly Mean DCS at Week 5(Baseline, Week 5)
- Change From Baseline in Weekly Mean DCS at Week 8(Baseline, Week 8)
- Change From Baseline in Weekly Mean DCS at Week 10(Baseline, Week 10)
- Change From Baseline in Weekly Mean DCS at Week 11(Baseline, Week 11)
- Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 8 Weeks of Treatment (Day 56)(Baseline, Day 56)
- Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score At Day 85/Early Termination(Baseline, Day 85/Early Termination)
- Percentage of Participants Reporting "Very Much Improved" or "Much Improved" According to the Patient's Global Impression of Change (PGIC) After 4 Weeks of Treatment (Day 28)(Day 28)
- Percentage of Participants Reporting "Very Much Improved" or "Much Improved" According to the PGIC After 8 Weeks of Treatment (Day 56)(Day 56)
- Percentage of Participants Reporting "Very Much Improved" or "Much Improved" According to the PGIC at Day 85/Early Termination(Day 85/Early Termination)
- Percentage of Participants Rated as "Very Much Improved" or "Much Improved" by Clinicians According to the Clinician's Global Impression of Change (CGIC) at Day 85/Early Termination(Day 85/Early Termination)
- Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year(Day 85/Early Termination)
- Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months(Day 85/Early Termination)
- Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks(Day 85/Early Termination)
- Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily(Day 85/Early Termination)
- Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84)(Day 84)
- Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84)(Day 84)
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