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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on October 21, 2014