- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01432730
A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006) (EPICC)
November 10, 2020 updated by: Afferent Pharmaceuticals, Inc.
A Study to Assess the Efficacy of AF-219, a P2X3 Receptor Antagonist, in Subjects With Chronic Cough (EPiCC)
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Gefapixant 600 mg>Placebo
Gefapixant, 600 mg, twice daily (BID), taken orally for 2 weeks followed by a 2-week washout period and then placebo to gefapixant, BID, taken orally for 2 weeks.
|
Oral tablets, BID
Other Names:
Oral tablets, BID
|
EXPERIMENTAL: Placebo>Gefapixant 600 mg
Placebo to gefapixant BID, taken orally for 2 weeks followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks.
|
Oral tablets, BID
Other Names:
Oral tablets, BID
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Daytime Objective Cough Frequency
Time Frame: Baseline (Day 0) and Day 14 of each study period
|
Daytime Objective Cough Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participants is awake.
24-hour sound recordings were collected using a digital recording device.
Change from baseline in awake cough frequency = (post-treatment awake cough frequency - baseline awake cough frequency).
A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
|
Baseline (Day 0) and Day 14 of each study period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS)
Time Frame: Baseline (Day 0) and Day 15 of each study period
|
Cough Severity VAS: scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 100mm with 0 representing no cough and 100 the most severe cough.
Change from baseline in daytime cough severity = (post-treatment daytime cough severity - baseline daytime cough severity).
A negative result indicates a decrease in cough severity, while a positive result indicates an increase in cough severity.
|
Baseline (Day 0) and Day 15 of each study period
|
Change From Baseline in Nighttime Objective Cough Frequency
Time Frame: Baseline (Day 0) and Day 14 of each study period
|
Nighttime Objective Cough Frequency = Total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep.
24 hour sound recording were collected with a digital recording device.
Change from baseline in nighttime cough frequency = (post-treatment nighttime cough frequency - baseline nighttime cough frequency).
A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
|
Baseline (Day 0) and Day 14 of each study period
|
Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS)
Time Frame: Baseline (Day 0) and Day 15 of each study period
|
Cough Severity VAS: scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 100mm with 0 representing no cough and 100 the most severe cough.
Change from baseline in nighttime cough severity = (post-treatment nighttime cough severity - baseline nighttime cough severity).
A negative result indicates a decrease in cough severity, while a positive result indicates an increase in cough severity.
|
Baseline (Day 0) and Day 15 of each study period
|
Change From Baseline of 24-hour Objective Cough Frequency
Time Frame: 24 hours at Baseline (Day 0) and Day 14 of each study period
|
Total (0-24 hours) Objective Cough Frequency = Total number of cough events during the monitoring period divided by the total duration (in hours, i.e., 24 hours mostly) for the monitoring period.
24-hour sound recordings were collected using a digital recording device.
A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
|
24 hours at Baseline (Day 0) and Day 14 of each study period
|
Global Rating of Change Score for Cough Frequency
Time Frame: Day 15 of each study period
|
At the end of each study period, participants were asked to complete the global rating of change scale questionnaire.
The participants were asked to record whether their cough frequency was "worse", "about the same", or "better".
If better or worse, the participants were then asked "by how much" with a 7-category rating scale.
Therefore, a 15-point ordered scale was used (1=minimum, a very great deal better to 15=maximum, a very great deal worse with a score of 8=indicating no change).
|
Day 15 of each study period
|
Global Rating of Change Score for Cough Severity
Time Frame: Day 15 of each study period
|
At the end of each study period, participants were asked to complete the global rating of change scale questionnaire.
The participants were asked to record whether their cough severity was "worse", "about the same", or "better".
If better or worse, the participants were then asked "by how much" with a 7-category rating scale.
Therefore, a 15-point ordered scale was used (1=minimum, a very great deal better to 15=maximum, a very great deal worse with a score of 8=indicating no change).
|
Day 15 of each study period
|
Change From Baseline in Cough-specific Quality of Life Questionnaire (CQLQ)
Time Frame: Baseline (Day 0) and Day 15 of each study period
|
The CQLQ Questionnaire included 28 items that described negative aspects of quality of life specific to chronic cough.
Subscales include: Physical complaints, Psychosocial issues, Functional abilities, Emotional wellbeing, Extreme physical complaints, and Personal safety fears.
Participants indicated their degree of agreement with each statement on a 4 point scale (1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree).
CQLQ scores (28 for least impact, 112 for highest impact) used a mixed effect model with terms for treatment sequence, participant within sequence, treatment, and period.
Change from baseline in CQLQ scores = (posttreatment CQLQ scores - baseline CQLQ scores).
A negative result indicates a decrease in CQLQ scores (lowest cough impact on health-related quality of life), while a positive result indicates an increase in CQLQ scores (highest cough impact on health-related quality of life).
|
Baseline (Day 0) and Day 15 of each study period
|
Change From Baseline in Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale
Time Frame: Baseline (Day 0) and Day 15 of each study period
|
UtCQ is determined through the use of a 100mm visual analogue scale (VAS) (ranging between 0 for "no urge to cough" and 100 for "severe urge to cough").
Change from baseline in UtCQ scores = (post-treatment UtCQ scores - baseline UtCQ scores).
A negative result indicates a decrease in UtCQ scores (lowest impact), while a positive result indicates an increase in UtCQ scores (highest impact).
|
Baseline (Day 0) and Day 15 of each study period
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Daytime Cough Frequency
Time Frame: Baseline (Day 0) of each study period
|
Daytime Objective Cough Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participants is awake.
24-hour sound recordings were collected using a digital recording device.
|
Baseline (Day 0) of each study period
|
Baseline Daytime Cough Severity Score Using a Visual Analogue Scale (VAS)
Time Frame: Baseline (Day 0) of each study period
|
Cough Severity VAS is scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 100mm with 0 representing no cough and 100 the most severe cough.
|
Baseline (Day 0) of each study period
|
Baseline Nighttime Objective Cough Frequency
Time Frame: Baseline (Day 0) of each study period
|
Nighttime Objective Cough Frequency is the total number of cough events during the monitoring period the participant is asleep divided by the total duration (in hours) for the monitoring period the participant is asleep.
24 hour sound recording were collected with a digital recording device.
|
Baseline (Day 0) of each study period
|
Baseline Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS)
Time Frame: Baseline (Day 0) of each study period
|
Nighttime cough severity was scored from 0 to 100 using a 10 mm visual analogue scale with 0 at 0mm and 100 at 100mm with 0 representing no cough and 100 the most severe cough.
|
Baseline (Day 0) of each study period
|
Baseline 24-Hour Objective Cough Frequency
Time Frame: Baseline (Day 0) of each study period
|
Total (0-24 hours) Objective Cough Frequency = Total number of cough events during the monitoring period divided by the total duration (in hours, i.e., 24 hours mostly) for the monitoring period.
24-hour sound recordings were collected using a digital recording device.
|
Baseline (Day 0) of each study period
|
Baseline Cough-specific Quality of Life Questionnaire (CQLQ)
Time Frame: Baseline (Day 0) of each study period
|
The CQLQ Questionnaire included 28 items that described negative aspects of quality of life specific to chronic cough.
Subscales include: Physical complaints, Psychosocial issues, Functional abilities, Emotional wellbeing, Extreme physical complaints, and Personal safety fears.
Participants indicated their degree of agreement with each statement on a 4 point scale (1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree).
CQLQ scores (28 for least impact, 112 for highest impact) used a mixed effect model with terms for treatment sequence, participant within sequence, treatment, and period.
Change from baseline in CQLQ scores = (posttreatment CQLQ scores - baseline CQLQ scores).
A negative result indicates a decrease in CQLQ scores (lowest cough impact on health-related quality of life), while a positive result indicates an increase in CQLQ scores (highest cough impact on health-related quality of life).
|
Baseline (Day 0) of each study period
|
Baseline Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale
Time Frame: Baseline (Day 0) of each study period
|
UtCQ is determined through the use of a 100mm visual analogue scale (VAS) (ranging between 0 for "no urge to cough" and 100 for "severe urge to cough").
|
Baseline (Day 0) of each study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 22, 2011
Primary Completion (ACTUAL)
February 7, 2013
Study Completion (ACTUAL)
February 21, 2013
Study Registration Dates
First Submitted
September 9, 2011
First Submitted That Met QC Criteria
September 12, 2011
First Posted (ESTIMATE)
September 13, 2011
Study Record Updates
Last Update Posted (ACTUAL)
November 24, 2020
Last Update Submitted That Met QC Criteria
November 10, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7264-006
- AF219-006 (OTHER: Afferent Pharmaceuticals)
- MK-7264-006 (OTHER: Merck)
- 2010-024283-18 (EUDRACT_NUMBER)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Cough
-
Trevi TherapeuticsRecruitingRefractory Chronic CoughCanada, United Kingdom
-
Mayo ClinicRecruitingRefractory Chronic CoughUnited States
-
Guangzhou Medical UniversityNingbo SensCure Biotechnology Co., Ltd.Recruiting
-
Stuart MazzoneMelbourne Health; Merck Sharp & Dohme LLC; Monash UniversityNot yet recruitingChronic CoughAustralia
-
ShionogiCompletedChronic CoughUnited States, United Kingdom, Japan, Ukraine, Poland, Czechia
-
Respivant Sciences GmbHRespivant Sciences Inc.TerminatedChronic Cough | IPF | Persistent Cough in IPFUnited States, United Kingdom, Netherlands, Australia, Belgium, New Zealand, Turkey, Italy, Germany, Czechia, Canada
-
Genentech, Inc.RecruitingChronic Refractory Cough (CRC) With Non-atopic Asthma | CRC With Atopic Asthma | Unexplained Chronic Cough | CRC With Chronic Obstructive Pulmonary Disease | CRC With Chronic Obstructive Pulmonary Disease With Chronic BronchitisUnited States, Australia, United Kingdom, Canada
-
Merck Sharp & Dohme LLCCompletedChronic CoughCanada, Czechia, Denmark, Hungary, Peru, Poland, Ukraine, United Kingdom, United States, Australia, China, Colombia, Germany, Guatemala, Israel, Italy, Malaysia, New Zealand, South Africa, Turkey
-
Bellus Health Inc. - a GSK companyRecruitingRefractory Chronic CoughKorea, Republic of, United States, Taiwan, Australia, New Zealand, Czechia, United Kingdom, Germany, Slovakia, India
Clinical Trials on Gefapixant
-
Afferent Pharmaceuticals, Inc.CompletedRefractory Chronic Cough
-
Afferent Pharmaceuticals, Inc.Completed
-
Afferent Pharmaceuticals, Inc.CompletedRefractory Chronic Cough
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompletedChronic CoughCanada, Czechia, Denmark, Hungary, Peru, Poland, Ukraine, United Kingdom, United States, Australia, China, Colombia, Germany, Guatemala, Israel, Italy, Malaysia, New Zealand, South Africa, Turkey
-
Merck Sharp & Dohme LLCCompletedRenal InsufficiencyUnited States
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompletedChronic CoughUnited States, Argentina, Canada, Czechia, Denmark, France, Hungary, Israel, Japan, Korea, Republic of, Peru, Poland, Spain, Taiwan, Turkey, Ukraine, United Kingdom
-
Merck Sharp & Dohme LLCCompletedChronic CoughUnited States, Argentina, Colombia, Germany, Guatemala, Israel, Korea, Republic of, Peru, Russian Federation, Spain, Ukraine, United Kingdom
-
Merck Sharp & Dohme LLCCompletedChronic CoughColombia, Guatemala, Korea, Republic of, Peru, Ukraine, United Kingdom, United States, Canada, Germany, Poland, Russian Federation, Spain