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| ID | Type | Description | Link |
|---|---|---|---|
| AF219-006 | Other Identifier | Afferent Pharmaceuticals | |
| MK-7264-006 | Other Identifier | Merck | |
| 2010-024283-18 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefapixant 600 mg>Placebo | Experimental | 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. |
|
| Placebo>Gefapixant 600 mg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefapixant | Drug | Oral tablets, BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0) and Day 14 of each study period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0) of each study period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25467586 | Derived | 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. |
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24 participants were enrolled and randomized from a single center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gefapixant 600 mg>Placebo | Gefapixant, 600 mg, twice daily (BID), taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then placebo, BID, taken orally for 2 weeks in Period 2 |
| FG001 | Placebo>Gefapixant 600mg | Placebo BID, taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks in Period 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Gefapixant, 600 mg, BID, taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then placebo to gefapixant, BID, taken orally for 2 weeks in Period 2 OR Placebo to gefapixant, BID, taken orally for 2 weeks in Period 1 followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks in Period 2 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Posted | Log Mean | Standard Error | Coughs/hour | Baseline (Day 0) and Day 14 of each study period |
|
Up to 59 days
An adverse event (AE) is any untoward medical occurrence in a study participant administered a study drug that does not necessarily have a causal relationship and is related or not related to the administration of the study drug or treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gefapixant 600 mg | Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| ID | Term |
|---|---|
| C000597312 | Gefapixant |
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| Placebo | Drug | Oral tablets, BID |
|
| 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. | 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. | 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. | 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). | 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). | 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). | 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). | Baseline (Day 0) and Day 15 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. | 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. | 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. | 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. | 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). | 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"). | Baseline (Day 0) of each study period |
| NOT COMPLETED |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Gefapixant 600 mg twice daily (BID) taken orally for 2 weeks |
| OG001 | Placebo | Placebo BID taken orally for 2 weeks |
|
|
|
| Secondary | 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. | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) and Day 15 of each study period |
|
|
|
|
| Secondary | 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. | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Posted | Log Mean | Standard Error | Coughs/hour | Baseline (Day 0) and Day 14 of each study period |
|
|
|
|
| Secondary | 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. | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) and Day 15 of each study period |
|
|
|
|
| Secondary | 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. | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Posted | Log Mean | Standard Error | Coughs/hour | 24 hours at Baseline (Day 0) and Day 14 of each study period |
|
|
|
|
| Secondary | 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). | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Day 15 of each study period |
|
|
|
|
| Secondary | 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). | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Day 15 of each study period |
|
|
|
|
| Secondary | 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). | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) and Day 15 of each study period |
|
|
|
|
| Secondary | 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). | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, received at least 1 dose of study drug, were compliant with the study procedure and had available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) and Day 15 of each study period |
|
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|
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| Other Pre-specified | 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. | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for daytime cough frequency. | Posted | Mean | Standard Deviation | Coughs/hour | Baseline (Day 0) of each study period |
|
|
|
| Other Pre-specified | 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. | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for daytime cough severity. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) of each study period |
|
|
|
| Other Pre-specified | 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. | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for nighttime cough frequency. | Posted | Mean | Standard Deviation | Coughs/hour | Baseline (Day 0) of each study period |
|
|
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| Other Pre-specified | 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. | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for nighttime cough severity. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) of each study period |
|
|
|
| Other Pre-specified | 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. | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for 24-hour objective cough frequency. | Posted | Mean | Standard Deviation | Coughs/hour | Baseline (Day 0) of each study period |
|
|
|
| Other Pre-specified | 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). | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for CQLQ. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) of each study period |
|
|
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| Other Pre-specified | 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"). | Analysis population consisted of all participants for Periods 1 and 2 who were randomized, were compliant with the study procedure and had available data at baseline for UtCQ. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Day 0) of each study period |
|
|
|
| 0 |
| 24 |
| 24 |
| 24 |
| EG001 | Placebo | Placebo BID taken orally for 2 weeks | 0 | 22 | 5 | 22 |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Anosmia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
The data generated in this clinical trial are the property of Sponsor and are confidential. Authorship on any publication or presentation of the results from this study will be govern by the executed Clinical Trial Agreement as well as being consistent with the Uniform Requirements of the International Committee of Medical Journal Editors.
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |