Condition category
Signs and Symptoms
Date applied
23/06/2009
Date assigned
23/09/2009
Last edited
24/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tim Harrison

ORCID ID

Contact details

Nottingham Respiratory Biomedical Research Unit
Clinical Sciences Building
City Hospital Site
Nottingham
NG5 1PB
United Kingdom
-
tim.harrison@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2

Study information

Scientific title

Macrolide antibiotics in the treatment of chronic idiopathic cough: a randomised double-blind, placebo-controlled, parallel-group trial

Acronym

MAC

Study hypothesis

Macrolide antibiotics are an effective treatment in chronic idiopathic cough.

Ethics approval

Nottingham Research Ethics Committee 2, 11/12/2008, ref: 08/H0408/121

Study design

Randomised double-blind placebo-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic idiopathic cough

Intervention

Azithromycin 500 mg for 3 days followed by 250 mg three times weekly for 7 weeks or matching placebo treatment regimen.

Intervention type

Drug

Phase

Phase III

Drug names

Azithromycin

Primary outcome measures

Leicester Cough Questionnaire score, measured after 8 weeks' treatment with azithromycin or placebo

Secondary outcome measures

1. Cough severity score
2. Adverse effects
Measured at study visits after 4 weeks, 8 weeks and 12 weeks

Overall trial start date

01/07/2009

Overall trial end date

01/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Non-smoking subjects aged 18 to 80 years (either sex) with idiopathic cough for at least 2 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. 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

Recruitment start date

01/07/2009

Recruitment end date

01/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham Respiratory Biomedical Research Unit
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Research Innovation Services
King's Meadow Campus
Nottingham
NG7 2NR
United Kingdom
-
paul.cartledge@nottingham.ac.uk

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Nottingham Respiratory Biomedical Research 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

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26836927

Publication citations

Additional files

Editorial Notes

24/08/2016: Publication reference added.