Chronic unexplained cough Signs and Symptoms Symptoms and signs involving the circulatory and respiratory systems
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour cough frequency. 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
| Measure | Time frame |
|---|---|
| 1. Leicester cough questionnaire score 2. Visual analogue score 3. Difference in sputum inflammatory markers 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. | — |
Countries
United Kingdom