A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)-China Extension
Study Details
Study Description
Brief Summary
The primary objective of this study will be to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period. It is hypothesized that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This study will have a main 24-week treatment period and a 28-week extension period of treatment. The China extension to MK-7264-030 (NCT03449147) will enroll a total of approximately 160 Chinese participants. The initial China Extension protocol (amendment 3) will include the Gefapixant 15 mg BID treatment arm; this treatment arm will not be included in subsequent protocol amendments (eg amendment 5).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Gefapixant 45 mg twice daily (BID) Participants will receive a gefapixant 45 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks). |
Drug: Gefapixant 45 mg twice daily (BID)
Gefapixant 45 mg tablet to be administered orally BID
Other Names:
|
| Experimental: Gefapixant 15 mg BID Participants will receive a gefapixant 15 mg tablet BID during the main study period (24 weeks) and also during the extension period (28 weeks). This arm is not included in protocol amendment 5 or later. |
Drug: Gefapixant 15 mg BID
Gefapixant 15 mg tablet to be administered orally BID
Other Names:
|
| Placebo Comparator: Placebo Participants will receive a matching placebo tablet BID during the 24-week main study period and during the 28-week extension period. |
Drug: Placebo
Placebo tablet administered orally BID
|
Outcome Measures
Primary Outcome Measures
- 24-hour Coughs per Hour at Week 24 [Week 24]
Assessment of 24-hour coughs per hour (average hourly cough frequency based on 24-hour sound recordings), to be evaluated using a digital recording device which records sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone.
- Percentage of Participants Experiencing At Least One Adverse Event (AE) During Treatment and Follow-up [Up to 54 weeks]
Assessment of participants who have at least one AE during the main study period (24 weeks), the treatment extension period (28 weeks), and during 2 weeks of follow-up by telephone.
- Percentage of Participants Who Have a Study Drug Discontinued Due to an AE [Up 52 weeks]
Assessment of participants who stop study treatment due to an AE during the main study period (24 weeks) or the treatment extension period (28 weeks).
Secondary Outcome Measures
- Change From Baseline of Awake Coughs Per Hour at Week 24 [Baseline, Week 24]
To evaluate the efficacy of gefapixant by assessment of coughs per hour while the participant is awake, evaluated using a chest contact sensor to record sounds from the lungs and trachea and a lapel microphone to record ambient sounds.
- Percentage of Participants With a ≥1.3-point Increase From Baseline in the Leicester Questionnaire (LCQ) Total Score at Week 24 [Baseline, Week 24]
To evaluate the ability of gefapixant to provide a clinically significant improvement in cough-specific health related quality of life (HRQoL), as indicated by a ≥1.3-point increase from Baseline in the LCQ total score at Week 24. The 19-item LCQ assesses the impact of cough severity in three HRQoL domains (physical, social and psychological). The LCQ is calculated as a mean score for each domain ranging from 1 to 7, with a total score ranging from 3 to 21.
- Percentage of Participants With a ≥30% Reduction From Baseline in 24-hour Coughs Per Hour at Week 24 [Baseline, Week 24]
To evaluate the efficacy of gefapixant based on clinically meaningful (≥30%) reduction from Baseline in 24-hour coughs per hour at Week 24. Coughs per hour are evaluated using a chest contact sensor to record sounds from the lungs and trachea and a lapel microphone to record ambient sounds.
- Percentage of Participants with ≥1.3-point Reduction From Baseline of Mean Weekly Cough Severity Diary (CSD) Total Score at Week 24 [Baseline, Week 24]
To evaluate the efficacy of gefapixant based on the percentage of participants with ≥1.3-point reduction of the mean weekly CSD total score at Week 24. Participants will record their cough frequency, intensity, and disruption due to cough using the 7-item CSD. Participants will rate each item using an 11-point scale ranging from 0 to 10 with higher scores indicating greater severity.
- Percentage of Participants with ≥2.7-point Reduction From Baseline of Mean Weekly CSD Total Score at Week 24 [Baseline, Week 24]
To evaluate the efficacy of gefapixant based on the percentage of participants with ≥2.7-point reduction of the mean weekly CSD total score at Week 24. Participants will record their cough frequency, intensity, and disruption due to cough using the 7-item CSD. Participants will rate each item using an 11-point scale ranging from 0 to 10 with higher scores indicating greater severity.
- Percentage of Participants With a ≥30 mm Reduction From Baseline in Cough Severity Visual Analog Scale (VAS) Score at Week 24 [Baseline, Week 24]
To evaluate the efficacy of gefapixant based on improvement from Baseline in cough severity, assessed by the proportion of participants with a ≥30 mm reduction from baseline in Cough Severity VAS score at Week 24. The VAS is a single-item questionnaire with the response on a 100- point scale ranging from 0 ("No Cough") to 100 ("Extremely Severe Cough").
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator
-
Has had chronic cough for at least 1 year with a diagnosis of refractory chronic cough or unexplained chronic cough
-
Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
-
Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)
Exclusion Criteria:
-
Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with greater than 20 pack-years
-
Has a history of respiratory tract infection or recent clinically significant change in pulmonary status
-
Has a history of chronic bronchitis
-
Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
-
Has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 at Screening OR an eGFR ≥30 mL/min/1.73 m2 and <50 mL/min/1.73 m^2 at Screening with unstable renal function
-
Has a history of malignancy <=5 years
-
Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
-
Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs
-
Has a known allergy/sensitivity or contraindication to gefapixant
-
Has donated or lost >=1 unit of blood within 8 weeks prior to the first dose of gefapixant
-
Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Fujian Medical University ( Site 5017) | Fuzhou | Fujian | China | 350005 |
| 2 | The First Affiliated Hospital of Guangzhou Medical University ( Site 5000) | Guangzhou | Guangdong | China | 510120 |
| 3 | Inner Mongolia Autonomous Region Hospital ( Site 5018) | Hohhot | Inner Mongolia | China | 010017 |
| 4 | The First Affiliated Hospital of Nanchang University ( Site 5012) | Nanchang | Jiangxi | China | 330006 |
| 5 | ShengJing Hospital of China Medical University ( Site 5024) | Shenyang | Liaoning | China | 110004 |
| 6 | Shanghai General Hospital ( Site 5010) | Shanghai | Shanghai | China | 200080 |
| 7 | The First Affiliated Hospital of Zhejiang University ( Site 5014) | Hangzhou | Zhejiang | China | 310003 |
| 8 | Peking University Third Hospital ( Site 5005) | Beijing | China | 100191 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 7264-030 China Extension
- MK-7264-030