A Phase 2 interventional study of Gefapixant and Placebo in Chronic Cough, sponsored by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Phase 2, Interventional, and Treatment
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.
346 studies on the registry are indexed under Cough; 71 are open to participants now.
This study's enrollment of 24 is below the median of 70 across 263 interventional studies indexed under Cough.
Browse Cough studies →Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Gefapixant · Drug: Placebo
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.
Drug: Gefapixant · Drug: Placebo
Oral tablets, BID
Also known as: AF-219, MK-7264
Oral tablets, BID
Change From Baseline in Daytime Objective Cough Frequency
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.
Time frame: Baseline (Day 0) and Day 14 of each study period
Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS)
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.
Time frame: Baseline (Day 0) and Day 15 of each study period
Change From Baseline in Nighttime Objective Cough Frequency
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.
Time frame: Baseline (Day 0) and Day 14 of each study period
Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS)
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.
Time frame: Baseline (Day 0) and Day 15 of each study period
Change From Baseline of 24-hour Objective Cough Frequency
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.
Time frame: 24 hours at Baseline (Day 0) and Day 14 of each study period
Global Rating of Change Score for Cough Frequency
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).
Time frame: Day 15 of each study period
Global Rating of Change Score for Cough Severity
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).
Time frame: Day 15 of each study period
Change From Baseline in Cough-specific Quality of Life Questionnaire (CQLQ)
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).
Time frame: Baseline (Day 0) and Day 15 of each study period
Change From Baseline in Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale
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).
Time frame: Baseline (Day 0) and Day 15 of each study period
Baseline Daytime Cough Frequency
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.
Time frame: Baseline (Day 0) of each study period
Baseline Daytime Cough Severity Score Using a Visual Analogue Scale (VAS)
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.
Time frame: Baseline (Day 0) of each study period
Baseline Nighttime Objective Cough Frequency
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.
Time frame: Baseline (Day 0) of each study period
Baseline Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS)
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.
Time frame: Baseline (Day 0) of each study period
Baseline 24-Hour Objective Cough Frequency
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.
Time frame: Baseline (Day 0) of each study period
Baseline Cough-specific Quality of Life Questionnaire (CQLQ)
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).
Time frame: Baseline (Day 0) of each study period
Baseline Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale
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").
Time frame: Baseline (Day 0) of each study period
24 participants were enrolled and randomized from a single center.
| Milestone | Gefapixant 600 mg>Placebo | Placebo>Gefapixant 600mg |
|---|---|---|
| Started | 12 | 12 |
| Completed | 10 | 12 |
| Not completed | 2 | 0 |
| Withdrew: Adverse event | 2 | 0 |
| Milestone | Gefapixant 600 mg>Placebo | Placebo>Gefapixant 600mg |
|---|---|---|
| Started | 10 | 12 |
| Completed | 10 | 8 |
| Not completed | 0 | 4 |
| Withdrew: Adverse event | 0 | 4 |
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.
| Coughs/hour | Gefapixant 600 mg | Placebo |
|---|---|---|
| Change From Baseline in Daytime Objective Cough Frequency | -0.5365 ± 0.1718 | 0.0523 ± 0.0462 |
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.
| Score on a scale | Gefapixant 600 mg | Placebo |
|---|---|---|
| Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS) | -21.5 ± 35.65 | -0.7 ± 19.01 |
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.
| Coughs/hour | Gefapixant 600 mg | Placebo |
|---|---|---|
| Change From Baseline in Nighttime Objective Cough Frequency | -0.3452 ± 0.2314 | 0.0690 ± 0.1767 |
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.
| Score on a scale | Gefapixant 600 mg | Placebo |
|---|---|---|
| Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS) | -16.1 ± 27.71 | -3.7 ± 22.05 |
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.
| Coughs/hour | Gefapixant 600 mg | Placebo |
|---|---|---|
| Change From Baseline of 24-hour Objective Cough Frequency | -0.5562 ± 0.1795 | 0.0298 ± 0.0459 |
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).
| Score on a scale | Gefapixant 600 mg | Placebo |
|---|---|---|
| Global Rating of Change Score for Cough Frequency | 5.83 ± 4.96 | 8.32 ± 2.28 |
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).
| Score on a scale | Gefapixant 600 mg | Placebo |
|---|---|---|
| Global Rating of Change Score for Cough Severity | 6.00 ± 4.94 | 8.23 ± 2.25 |
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).
| Score on a scale | Gefapixant 600 mg | Placebo |
|---|---|---|
| Change From Baseline in Cough-specific Quality of Life Questionnaire (CQLQ) | -10.8 ± 14.23 | -1.4 ± 6.48 |
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).
| Score on a scale | Gefapixant 600 mg | Placebo |
|---|---|---|
| Change From Baseline in Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale | -27.2 ± 42.07 | -6.5 ± 28.59 |
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.
| Coughs/hour | Gefapixant 600 mg | Placebo |
|---|---|---|
| Baseline Daytime Cough Frequency | 37.09 ± 32.23 | 65.45 ± 163.36 |
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.
| Score on a scale | Gefapixant 600 mg | Placebo |
|---|---|---|
| Baseline Daytime Cough Severity Score Using a Visual Analogue Scale (VAS) | 48.8 ± 20.73 | 52.7 ± 16.10 |
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.
| Coughs/hour | Gefapixant 600 mg | Placebo |
|---|---|---|
| Baseline Nighttime Objective Cough Frequency | 4.34 ± 7.79 | 7.78 ± 23.80 |
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.
| Score on a scale | Gefapixant 600 mg | Placebo |
|---|---|---|
| Baseline Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS) | 31.5 ± 23.86 | 28.8 ± 24.88 |
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.
| Coughs/hour | Gefapixant 600 mg | Placebo |
|---|---|---|
| Baseline 24-Hour Objective Cough Frequency | 26.63 ± 22.63 | 44.70 ± 105.16 |
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).
| Score on a scale | Gefapixant 600 mg | Placebo |
|---|---|---|
| Baseline Cough-specific Quality of Life Questionnaire (CQLQ) | 56.3 ± 10.40 | 56.2 ± 10.28 |
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").
| Score on a scale | Gefapixant 600 mg | Placebo |
|---|---|---|
| Baseline Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale | 63.1 ± 23.10 | 62.5 ± 19.99 |
Collected over Up to 59 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gefapixant 600 mg | — | 0/24 (0%) | 24/24 (100%) |
| Placebo | — | 0/22 (0%) | 5/22 (22.7%) |
| Event | Gefapixant 600 mg | Placebo |
|---|---|---|
| DysgeusiaNervous system disorders | 21/24 | 0/22 |
| HypogeusiaNervous system disorders | 13/24 | 0/22 |
| NauseaGastrointestinal disorders | 9/24 | 1/22 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 5/24 | 1/22 |
| Salivary hypersecretionGastrointestinal disorders | 3/24 | 1/22 |
| HeadacheNervous system disorders | 3/24 | 1/22 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/24 | 1/22 |
| NasopharyngitisInfections and infestations | 1/24 | 2/22 |
| Vision blurredEye disorders | 2/24 | 0/22 |
| ConstipationGastrointestinal disorders | 2/24 | 0/22 |
All randomized participants
| Age, Continuous(Years) | All Participants |
|---|---|
| Mean | 54.5 ± 11.1 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 18 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 24 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)