Condition category
Signs and Symptoms
Date applied
24/07/2007
Date assigned
06/08/2007
Last edited
26/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nadia Yousaf

ORCID ID

Contact details

Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

ELLE

Study hypothesis

Long term low dose erythromycin will improve both objective and subjective markers of chronic unexplained cough.

Ethics approval

Leicestershire, Northamptonshire and Rutland Research Ethics Committee 1, 26th October 2007 (ref: 07/H0406/193).

Study design

Randomised double-blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Erythromycin

Primary outcome measures

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 measures

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.

Overall trial start date

01/09/2007

Overall trial end date

01/08/2009

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant 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

Recruitment start date

01/09/2007

Recruitment end date

01/08/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glenfield Hospital
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

c/o Professor David Rowbotham
Leicester General Hospital
Research Office
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor type

Government

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Glenfield Hospital Clinical Trials Unit (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20965928

Publication citations

  1. Results

    Yousaf N, Monteiro W, Parker D, Matos S, Birring S, Pavord ID, Long-term low-dose erythromycin in patients with unexplained chronic cough: a double-blind placebo controlled trial., Thorax, 2010, 65, 12, 1107-1110, doi: 10.1136/thx.2010.142711.

Additional files

Editorial Notes