A Study to Assess the Efficacy of Gefapixant (MK-7264/AF-219), in Participants With Chronic Cough (MK-7264-006) (EPICC)

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

Status and phase: Completed; Phase 2

Conditions: Chronic Cough

Treatments: Drug: Placebo; Drug: Gefapixant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01432730

2010-024283-18 (EudraCT Number)

MK-7264-006 (Other Identifier)

AF219-006 (Other Identifier)

7264-006

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of cough for more than 8 weeks
• Normal chest radiograph
• Idiopathic or treatment resistant cough (idiopathic defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation or a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip [treatment-resistant]).

Exclusion criteria

• Current smoker
• Individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
• Treatment with an angiotensin-converting-enzyme inhibitor (ACE-inhibitor) as the potential cause of a participant's cough, or requiring treatment with an ACE-inhibitor during the study or within 4 weeks prior to Day 0
• Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) <60%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Gefapixant 600 mg>Placebo

Experimental group

Description:

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.

Treatment:

Drug: Gefapixant

Drug: Placebo

Placebo>Gefapixant 600 mg

Experimental group

Description:

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.

Treatment:

Drug: Gefapixant

Drug: Placebo