An 8-Week Refractory Chronic Cough Study (MK-7264-021)

Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 2

Conditions: Refractory Chronic Cough

Treatments: Drug: Placebo (for gefapixant); Drug: Gefapixant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02612623

7264-021

MK-7264-021 (Other Identifier)

AF219-021 (Other Identifier)

Details and patient eligibility

About

This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant (AF-219) in participants with refractory chronic cough.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women and Men between 18 and 80 years of age inclusive
• Have refractory chronic cough
• Women of child-bearing potential must use 2 forms of acceptable birth control
• Have provided written informed consent.
• Are willing and able to comply with all aspects of the protocol.

Exclusion criteria

• Current smoker
• Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) < 60%
• History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline
• History of opioid use within 1 week of the Baseline Visit
• Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
• History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with <3 excised basal cell carcinomas)
• Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP) >90 mm Hg
• Significantly abnormal laboratory tests at Screening
• Clinically significant abnormal electrocardiogram (ECG)
• Pregnant or Breastfeeding
• Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or Sponsor, would make the participants inappropriate for entry into this trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups

Gefapixant 15 mg twice daily

Experimental group

Description:

Two 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks

Treatment:

Drug: Gefapixant

Gefapixant 30 mg twice daily

Experimental group

Description:

Four 7.5 mg gefapixant tablets administered by mouth twice daily for 8 weeks

Treatment:

Drug: Gefapixant

Gefapixant 50 mg twice daily

Experimental group

Description:

One 50 mg gefapixant tablet administered by mouth twice daily for 8 weeks

Treatment:

Drug: Gefapixant

Placebo to match gefapixant

Experimental group

Description:

Matching placebo tablets administered by mouth twice daily for 8 weeks

Treatment:

Drug: Placebo (for gefapixant)