Phase 2
N=24
A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006)
Chronic Cough
Bottom Line
View on ClinicalTrials.gov: NCT01432730 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Change From Baseline in Daytime Objective Cough Frequency — -0.5365; 0.0523 Coughs/hour — p=0.0003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gefapixant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Daytime Objective Cough Frequency |
-0.5365; 0.0523 | 0.0003 sig |
| SECONDARY Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS) |
-21.5; -0.7 | 0.003 sig |
| SECONDARY Change From Baseline in Nighttime Objective Cough Frequency |
-0.3452; 0.0690 | 0.057 |
| SECONDARY Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS) |
-16.1; -3.7 | 0.172 |
| SECONDARY Change From Baseline of 24-hour Objective Cough Frequency |
-0.5562; 0.0298 | 0.001 sig |
| SECONDARY Global Rating of Change Score for Cough Frequency |
5.83; 8.32 | 0.033 sig |
| SECONDARY Global Rating of Change Score for Cough Severity |
6.00; 8.23 | 0.049 sig |
| SECONDARY Change From Baseline in Cough-specific Quality of Life Questionnaire (CQLQ) |
-10.8; -1.4 | 0.018 sig |
| SECONDARY Change From Baseline in Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale |
-27.2; -6.5 | 0.035 sig |
Summary
This is a randomised, double-blind, placebo-controlled, crossover, single centre study of gefapixant (AF-219/MK-7264) in participants with idiopathic or treatment resistant chronic cough designed to evaluate the effectiveness of gefapixant in reducing daytime objective cough frequency.
Eligibility Criteria
Inclusion Criteria
- History of cough for more than 8 weeks
- Normal chest radiograph
- Idiopathic or treatment resistant cough (idiopathic defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation or a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip [treatment-resistant]).
Exclusion Criteria
- Current smoker
- Individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
- Treatment with an angiotensin-converting-enzyme inhibitor (ACE-inhibitor) as the potential cause of a participant's cough, or requiring treatment with an ACE-inhibitor during the study or within 4 weeks prior to Day 0
- Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) <60%
Data sourced from ClinicalTrials.gov (NCT01432730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.