A Study to Assess the Efficacy of AF-219, a P2X3 Receptor Antagonist, in Subjects With Chronic Cough

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01432730
First received: September 9, 2011
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

This is a randomised, double-blind, placebo-controlled, crossover, single centre study of AF-219 in subjects with idiopathic chronic cough designed to evaluate the effectiveness of AF-219 in reducing daytime objective cough frequency.


Condition Intervention Phase
Chronic Cough
Drug: AF-219
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Assess the Efficacy of AF-219, a P2X3 Receptor Antagonist, in Subjects With Chronic Cough

Resource links provided by NLM:


Further study details as provided by Afferent Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change from Baseline in daytime objective cough frequency after 2 weeks AF-219 therapy compared with placebo treatment. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AF-219 Drug: AF-219
Oral tablets, BID
Placebo Comparator: Placebo Drug: Placebo
Oral tablets, BID

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ACE-inhibitor as the potential cause of a subject's cough, or requiring treatment with an ACE-inhibitor during the study or within 4 weeks prior to Day 0
  • FEV1/FVC <60%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432730

Locations
United Kingdom
North West Lung Research Centre, Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Afferent Pharmaceuticals, Inc.
Investigators
Principal Investigator: Jaclyn A Smith, MB, ChB, MRCP, PhD University Hospital of South Manchester
  More Information

No publications provided

Responsible Party: Afferent Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01432730     History of Changes
Other Study ID Numbers: AF219-006
Study First Received: September 9, 2011
Last Updated: January 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014