Clinical trial NCT01432730: A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006)
Official title: A Study to Assess the Efficacy of AF-219, a P2X3 Receptor Antagonist, in Subjects With Chronic Cough (EPiCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Cough
Lead sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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%

Primary outcomes:
measure: Change From Baseline in Daytime Objective Cough Frequency
timeFrame: Baseline (Day 0) and Day 14 of each study period
Secondary outcomes:
measure: Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS)
timeFrame: Baseline (Day 0) and Day 15 of each study period
measure: Change From Baseline in Nighttime Objective Cough Frequency
timeFrame: Baseline (Day 0) and Day 14 of each study period
measure: Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS)
timeFrame: Baseline (Day 0) and Day 15 of each study period
measure: Change From Baseline of 24-hour Objective Cough Frequency
timeFrame: 24 hours at Baseline (Day 0) and Day 14 of each study period
measure: Global Rating of Change Score for Cough Frequency
timeFrame: Day 15 of each study period
measure: Global Rating of Change Score for Cough Severity
timeFrame: Day 15 of each study period
measure: Change From Baseline in Cough-specific Quality of Life Questionnaire (CQLQ)
timeFrame: Baseline (Day 0) and Day 15 of each study period
measure: Change From Baseline in Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale
timeFrame: Baseline (Day 0) and Day 15 of each study period
Other outcomes:
measure: Baseline Daytime Cough Frequency
timeFrame: Baseline (Day 0) of each study period
measure: Baseline Daytime Cough Severity Score Using a Visual Analogue Scale (VAS)
timeFrame: Baseline (Day 0) of each study period
measure: Baseline Nighttime Objective Cough Frequency
timeFrame: Baseline (Day 0) of each study period
measure: Baseline Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS)
timeFrame: Baseline (Day 0) of each study period
measure: Baseline 24-Hour Objective Cough Frequency
timeFrame: Baseline (Day 0) of each study period
measure: Baseline Cough-specific Quality of Life Questionnaire (CQLQ)
timeFrame: Baseline (Day 0) of each study period
measure: Baseline Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale
timeFrame: Baseline (Day 0) of each study period
Locations:
Study officials:
affiliation: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Abdulqawi R, Dockry R, Holt K, Layton G, McCarthy BG, Ford AP, Smith JA. P2X3 receptor antagonist (AF-219) in refractory chronic cough: a randomised, double-blind, placebo-controlled phase 2 study. Lancet. 2015 Mar 28;385(9974):1198-205. doi: 10.1016/S0140-6736(14)61255-1. Epub 2014 Nov 25.