Are macrolide antibiotics effective in chronic idiopathic cough?

ISRCTN ISRCTN75749391
DOI https://doi.org/10.1186/ISRCTN75749391
Secondary identifying numbers 2
Submission date
23/06/2009
Registration date
23/09/2009
Last edited
24/08/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Cough is an extremely common symptom, and usually settles by itself without any treatment. A small number of people experience a more persistent cough which lasts for more than 8 weeks. In most cases there is an underlying cause for which we currently have established treatments. For cases where there is no underlying cause, or where current treatment does not improve symptoms, there is no treatment at the moment. Several patients seen in our clinic have seen an improvement in their cough with the antibiotic azithromycin. We designed this study to test the effect of this treatment in a group of patients with persistent cough, and to see if we can identify which patients may benefit from this antibiotic.

Who can participate?
Non-smoking subjects aged 18 to 80 (either sex) with idiopathic cough for at least 2 months.

What does the study involve?
Before taking part, you will be screened to make sure there is no underlying cause for your cough, and that you have had a proper trial of appropriate treatments before taking a trial drug. If you take part in this study, you will be asked to take one tablet three times a week for 8 weeks in addition to your usual medication. At each study visit we will ask you to rate the severity of your cough, and complete a questionnaire measuring different aspects of your cough. You will also provide a breath sample to measure inflammation in the lungs, and a blood sample at each visit. The study is a placebo-controlled trial, so half of the participants will be randomly allocated to take a dummy pill which resembles the active tablet but has no active effects. Neither you nor the trial staff will be aware which treatment you are receiving for the duration of the trial, but you will be informed of your treatment allocation at the end of the trial.

What are the possible benefits and risks of participating?
The main benefits are that your cough may improve, or that you help to develop an additional treatment for patients with cough. Azithromycin is a commonly prescribed antibiotic that has been in use for many years. The main side effects that some people experience are nausea, vomiting, smell and taste disturbances, abdominal discomfort, diarrhoea and headache. Less common side effects are effects on liver blood tests, joint and muscle aches. Other side effects are rare.

Where is the study run from?
Nottingham Respiratory Biomedical Research Unit (UK)

When is the study starting and how long is it expected to run for?
July 2009 to July 2011

Who is funding the study?
Nottingham Respiratory Biomedical Research Unit (UK)

Who is the main contact?
Dr Tim Harrison
tim.harrison@nottingham.ac.uk

Contact information

Dr Tim Harrison
Scientific

Nottingham Respiratory Biomedical Research Unit
Clinical Sciences Building
City Hospital Site
Nottingham
NG5 1PB
United Kingdom

Email tim.harrison@nottingham.ac.uk

Study information

Study designRandomised double-blind placebo-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMacrolide antibiotics in the treatment of chronic idiopathic cough: a randomised double-blind, placebo-controlled, parallel-group trial
Study acronymMAC
Study objectivesMacrolide antibiotics are an effective treatment in chronic idiopathic cough.
Ethics approval(s)Nottingham Research Ethics Committee 2, 11/12/2008, ref: 08/H0408/121
Health condition(s) or problem(s) studiedChronic idiopathic cough
InterventionAzithromycin 500 mg for 3 days followed by 250 mg three times weekly for 7 weeks or matching placebo treatment regimen.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Azithromycin
Primary outcome measureLeicester Cough Questionnaire score, measured after 8 weeks' treatment with azithromycin or placebo
Secondary outcome measures1. Cough severity score
2. Adverse effects
Measured at study visits after 4 weeks, 8 weeks and 12 weeks
Overall study start date01/07/2009
Completion date01/07/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexBoth
Target number of participants60
Key inclusion criteriaNon-smoking subjects aged 18 to 80 years (either sex) with idiopathic cough for at least 2 months
Key exclusion criteria1. Active smoking or smoking history in excess of 20 pack years
2. Non-idiopathic cough or other major co-morbidity including abnormal liver function tests
3. Medication known to interact with azithromycin
Date of first enrolment01/07/2009
Date of final enrolment01/07/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Nottingham Respiratory Biomedical Research Unit
Nottingham
NG5 1PB
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Research Innovation Services
King's Meadow Campus
Nottingham
NG7 2NR
England
United Kingdom

Email paul.cartledge@nottingham.ac.uk
Website http://www.nottingham.ac.uk/
ROR logo "ROR" https://ror.org/01ee9ar58

Funders

Funder type

Hospital/treatment centre

Nottingham Respiratory Biomedical Research Unit (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2016 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

24/08/2016: Publication reference added.