The effect of long term low dose erythromycin on cough frequency in chronic unexplained cough: a randomised, double blind, placebo conrolled, parallel group trial - macrolides in chronic cough
Phase 1
- Conditions
- Chronic unexplained cough
- Registration Number
- EUCTR2007-000750-31-GB
- Lead Sponsor
- niversity Hospitals of Leciester NHS trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Cough lasting greater than 8 weeks which remains unexplained after routine clinical assessment as outlined in the British Thoracic Society Cough guidelines document.
Normal spirometry values
Normal methocholine challange test
Normal sputum eosinophillia
No response to a 3 month trial of a high dose PPI
No response to a trial of a nasal steriod
Normal CT thorax
Non smokers with a less than 10 pack year smoking history
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Intolerance to macrolides
Pregnant
Breastfeeding
Unable to consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of long term low dose erythromycin on objective and subjective markers of cough in chronic unexplained cough;Secondary Objective: Determine which radiological and inflammatroy features of cough makes it more likely to respond to erythromycin.;Primary end point(s): cough frequency before, during, at the end of and 3 months following treatment with a macrolide antibiotic.
- Secondary Outcome Measures
Name Time Method