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

ISRCTN	ISRCTN75393495
DOI	https://doi.org/10.1186/ISRCTN75393495
Protocol serial number	1
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	Glenfield Hospital Clinical Trials Unit (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Nadia Yousaf
Scientific

Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Primary study design	Interventional
Study design	Randomised double-blind placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ELLE
Study objectives	Long term low dose erythromycin will improve both objective and subjective markers of chronic unexplained cough.
Ethics approval(s)	Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1, 26th October 2007 (ref: 07/H0406/193).
Health condition(s) or problem(s) studied	Chronic unexplained cough
Intervention	250 mg of erythromycin once a day for three months or placebo once a day for three months.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Erythromycin
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/08/2009

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	40
Key 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)
Key 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
Date of first enrolment	01/09/2007
Date of final enrolment	01/08/2009

Glenfield Hospital

Leicester
LE3 9QP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2010		Yes	No