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
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
Scientific
Nottingham Respiratory Biomedical Research Unit
Clinical Sciences Building
City Hospital Site
Nottingham
NG5 1PB
United Kingdom
| tim.harrison@nottingham.ac.uk |
Study information
| Study design | Randomised double-blind placebo-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Macrolide antibiotics in the treatment of chronic idiopathic cough: a randomised double-blind, placebo-controlled, parallel-group trial |
| Study acronym | MAC |
| Study objectives | Macrolide 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/07/2009 |
| Completion date | 01/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Non-smoking subjects aged 18 to 80 years (either sex) with idiopathic cough for at least 2 months |
| Key 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 |
| Date of first enrolment | 01/07/2009 |
| Date of final enrolment | 01/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NG5 1PB
United Kingdom
Sponsor information
University/education
Research Innovation Services
King's Meadow Campus
Nottingham
NG7 2NR
England
United Kingdom
| paul.cartledge@nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
