None listed
Conditions
Interventions
Gefapixant Type of group
Placebo tablet identical to Gefapixant 45mg, oral administration, twice daily (BID) for 12 weeks .
Sponsors
Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Has a chest radiograph or CT thorax (within 1 year 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 subinvestigator. 2. Has chronic cough (defined as duration of >8 weeks after onset of cough symptoms) for <12 months prior to the screening visit (ie, <14 months after onset of cough symptoms), per participant report and/or medical history. 3. Has a diagnosis of refractory chronic cough or unexplained chronic cough. 4. Has a score of ≥40 mm on the Cough Severity VAS at Screening/Visit 1 and Randomization/Visit 2. 5. Is male or female, at least 18 years of age, at the time of signing the informed consent. 6. A female participant is eligible to participate if she is not pregnant or breastfeeding. 7. Provides written informed consent for the study (or legally acceptable representative, if applicable). The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research. 8. Is willing and able to comply with all aspects of the protocol, including agreeing not to smoke during the study and demonstrating an ability to follow study procedures (including completion of the LCQ, CSD, and Cough Severity VAS) to the satisfaction of the investigator/qualified designee prior to randomization Please refer to the protocol for more information.
Exclusion criteria
Exclusion criteria: 1. Is a current smoker. 2. Has given up smoking within 12 months of Screening/Visit 1. 3. Is a former smoker with a smoking history greater than 20 pack-years (eg, 1 pack [20 cigarettes] per day for 20 years). 4. Has a FEV1/ FVC ratio <60%. 5. Has a history of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status within 4 weeks of Screening/Visit 1. 6. Has a history of chronic bronchitis, defined as a cough that produces a clinically significant amount of sputum (greater than approximately 1 tablespoon of phlegm) that occurs every day for at least 3 months in a row. 7. Has an estimated eGFR <30 mL/min/1.73 m2 at Screening/Visit 1 OR eGFR ≥30 mL/min/1.73 m2 and <50 mL/min/1.73 m2 at Screening/Visit 1 with unstable renal function (defined as a ≥50% increase of serum creatinine compared to a value obtained at least 6 months prior to Screening/Visit 1). 8. Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. 9. Is, at the time of Screening/Visit 1, a user of recreational or illicit drugs or has a recent history (within the last year) of drug or alcohol abuse or dependence. 10. Has a history of anaphylaxis or cutaneous adverse drug reaction (with or without systemic symptoms) to sulfonamide antibiotics or other sulfonamide-containing drugs. 11. Has a known allergy/sensitivity or contraindication to gefapixant or its excipients. 12. Has donated or lost ≥1 unit of blood (approximately 300 mL) within 8 weeks prior to the first dose of gefapixant. 13. Is a WOCBP who has a positive urine pregnancy test at Visit 1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 14. Requires treatment with a therapy that does not adhere to the guidance parameters specified in Section 6.5 of the Protocol. 15. Has previously received gefapixant or other P2X3 antagonists. 16. Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days of participating in this current study. 17. Has significantly abnormal laboratory tests at Screening/Visit 1. 18. Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results, and in the judgment of the investigator or Sponsor, would make the participant inappropriate for entry into this study. 19. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study Please refer to the protocol for more information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Longitudinal ANCOVA Model. Measure:Leicester Cough Questionnaire (LCQ) total score. Timepoints:Will measure change from baseline of the scores collected at Week 6 and Week 12 of treatment. ; Outcome name:Miettinen and Nurminen method. Measure:Proportion of adverse events (AE) and Discontinuation of study intervention due to AEs. Timepoints:From the time of intervention allocation/ randomization through 14 days following cessation of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Longitudinal ANCOVA Model. Measure:Cough Severity (Visual Analog Scale) VAS score. Timepoints:Will measure change from baseline of the scores collected at Week 12 of treatment. | — |
Countries
Argentina, Canada, Colombia, Germany, Guatemala, Israel, Korea South, Peru, Poland, Russian Federation, Spain, Ukraine, United Kindgdom, United States
Contacts
Public ContactNelva Garcia
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed