| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN75393495 |
| Date ISRCTN assigned | 06/08/2007 |
| Local reference number(s) | 1 |
| Public title | The Effect of Long term Low dose Erythromycin on cough frequency in chronic unexplained cough: a randomised double-blind placebo controlled parallel group trial |
| Scientific title |
|
| Acronym | ELLE |
| Disease/condition/study domain | Chronic unexplained cough |
| Study hypothesis | Long term low dose erythromycin will improve both objective and subjective markers of chronic unexplained cough. |
| Design/methodology | Randomised double-blind placebo controlled parallel group trial |
| Research ethics review | Ethics approval pending as of 24th July 2007. |
| Countries of trial | United Kingdom |
| Participants - 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) |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/09/2007 |
| Anticipated end date | 01/08/2009 |
| Status of trial | Ongoing |
| Target number of participants | 40 |
| Interventions | 250 mg of erythromycin once a day for three months or placebo once a day for three months. |
| 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. |
| 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. |
| Sources of funding | Glenfield Hospital Clinical Trials Unit (UK) |
| Sponsor name | University Hospitals of Leicester NHS Trust (UK) |
| Sponsor details | c/o Professor David Rowbotham
Leicester General Hospital
Research Office
Gwendolen Road
Leicester
United Kingdom
LE5 4PW |
| Sponsor website | http://www.uhl-tr.nhs.uk/ |
| Contact name | Dr Nadia Yousaf |
| Contact details | Glenfield Hospital
Groby Road
Leicester
United Kingdom
LE3 9QP |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN75393495 |
| Date last extracted from ISRCTN register | 17/04/2008 |
