Ph3B recently diagnosed cough in adults

Phase 1

• Conditions: Chronic Cough; MedDRA version: 21.1Level: LLTClassification code 10066656Term: Chronic coughSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-002308-42-GB
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-18
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 414

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. Meet a certain cough severity score at certain visits.
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, and at least one of the following conditions applies:
- Is not a woman of childbearing potential (WOCBP)
OR
- Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 2 weeks (14 days) after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
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.
Study Participation
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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 207
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 207

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 within 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, including:
a. alkaline phosphatase, ALT, AST >200% of the upper limit of normal, or bilirubin >150% of the upper limit of normal.
b. hemoglobin <10 g/dL, WBC count <2500 mm3 (<2.5 × 1000/µL), neutrophil count <1500 mm3 (<1.5 × 1000/µL), platelet count <100 × 1000/mm3 (<100 × 1000/uL).
For any of the above listed laboratory assessments, 1 repeat measurement will be allowed at the investigator’s discretion, before being considered a screen failure.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified