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The Effect of Long term Low dose Erythromycin on cough frequency in chronic unexplained cough: a randomised double-blind placebo controlled parallel group trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75393495
Enrollment
40
Registered
2007-08-06
Start date
2007-09-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic unexplained cough Signs and Symptoms Symptoms and signs involving the circulatory and respiratory systems

Interventions

250 mg of erythromycin once a day for three months or placebo once a day for three months.

Sponsors

University Hospitals of Leicester NHS Trust (UK)
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026