A Randomized, Parallel, Double-Blind Study to Assess the Efficacy and Tolerability of AF-219 in Subjects With Refractory Chronic Cough
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.
研究概览
简要总结
This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.
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 (FEV1)/Forced Vital Capacity (FVC) < 60%
- •History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline
- •History of opioid use within 1 week of the Baseline Visit
- •Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
- •History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with <3 excised basal cell carcinomas)
- •Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
- •Significantly abnormal laboratory tests at Screening
- •Clinically significant abnormal electrocardiogram (ECG)
- •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 participants inappropriate for entry into this trial
研究组 & 干预措施
Gefapixant 15 mg twice daily
Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
干预措施: Gefapixant (Drug)
Gefapixant 30 mg twice daily
Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks
干预措施: Gefapixant (Drug)
Gefapixant 50 mg twice daily
One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks
干预措施: Gefapixant (Drug)
Placebo to match gefapixant
Matching placebo tablets administered by mouth twice daily for 8 weeks
干预措施: Placebo (for gefapixant) (Drug)
结局指标
主要结局
Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.
时间窗: Baseline and Week 8 (Day 56)
Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0, and after administration of the study drug on Day 56. The cough frequency is the coughs/hr over each 24 hour period. An independent cough monitoring core lab provided documentation of the time of each cough event over each 24-hour period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency.
次要结局
未报告次要终点