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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26836927