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ISRCTN
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ISRCTN75393495
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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ELLE
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Serial number at source
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1
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Study hypothesis
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Long term low dose erythromycin will improve both objective and subjective markers of chronic unexplained cough.
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Ethics approval
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Ethics approval received from the Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1 on the 26th October 2007 (ref: 07/H0406/193).
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Study design
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Randomised double-blind placebo controlled parallel group trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic unexplained cough
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2007
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Anticipated end date
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01/08/2009
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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40
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Interventions
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250 mg of erythromycin once a day for three months or placebo once a day for three months.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Glenfield Hospital Clinical Trials Unit (UK)
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Trial website
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Publications
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Contact name
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Dr
Nadia
Yousaf
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Address
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Glenfield Hospital
Groby Road
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City/town
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Leicester
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Zip/Postcode
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LE3 9QP
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Country
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United Kingdom
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Sponsor
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University Hospitals of Leicester NHS Trust (UK)
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Address
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c/o Professor David Rowbotham
Leicester General Hospital
Research Office
Gwendolen Road
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City/town
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Leicester
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Zip/Postcode
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LE5 4PW
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Country
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United Kingdom
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Sponsor website:
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http://www.uhl-tr.nhs.uk/
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Date applied
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24/07/2007
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Last edited
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29/04/2008
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Date ISRCTN assigned
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06/08/2007
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