The Effect of Long term Low dose Erythromycin on cough frequency in chronic unexplained cough: a randomised double-blind placebo controlled parallel group trial
Completed
- Conditions
- Chronic unexplained coughSymptoms and signs involving the circulatory and respiratory systemsSigns and Symptoms
- Registration Number
- ISRCTN75393495
- Lead Sponsor
- niversity Hospitals of Leicester NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Cough lasting greater than eight weeks
2. Normal Spirometry
3. A Provocative Concentration of methacholine required to cause a 20% fall (PC20) in Forced Expiratory Volume in one second (FEV1) of greater than 8 mg/ml
4. A normal sputum eosinophil count (less than 3%)
5. No response to a three-month trial of treatment with a high dose Proton-Pump Inhibitor (PPI)
6. No response to a trial of a nasal steroid
7. A normal thoracic Computed Tomography (CT)
Exclusion Criteria
1. Current smokers or past smokers with a greater than 10 pack year history will be excluded
2. Those with a history of intolerance macrolide antibiotics
3. Pregnant or breastfeeding women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 24-hour cough frequency.<br><br>Primary and secondary endpoints will be measured at baseline, 6 weeks into treatment, at 3 months (at the end of treatment) and at 3 months after the end of treatment.
- Secondary Outcome Measures
Name Time Method 1. Leicester cough questionnaire score<br>2. Visual analogue score<br>3. Difference in sputum inflammatory markers<br><br>Primary and secondary endpoints will be measured at baseline, 6 weeks into treatment, at 3 months (at the end of treatment) and at 3 months after the end of treatment.