Macrolides in refractory asthma
| ISRCTN | ISRCTN93221282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93221282 |
| Protocol serial number | Final version 1.1 |
| Sponsor | University of Nottingham (UK) |
| Funder | University of Nottingham (UK) |
- Submission date
- 23/10/2008
- Registration date
- 23/01/2009
- Last edited
- 20/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Respiratory Medicine
Clinical Sciences Building
City Hospital site
Nottingham
NG5 1PB
United Kingdom
| Phone | +44 (0)115 823 1247 |
|---|---|
| tim.harrison@nottingham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised two-period cross-over placebo-controlled trial |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | MACrolides in Refractory Asthma: a single-centre randomised placebo-controlled two-period cross-over trial |
| Study acronym | MACRA |
| Study objectives | Azithromycin improves bronchial hyper-responsiveness in patients with refractory asthma. |
| Ethics approval(s) | Nottingham Research Ethics Committee 2, 06/06/2008, ref: 08/H0408/64 |
| Health condition(s) or problem(s) studied | Refractory asthma |
| Intervention | Azithromycin 250 mg three times a week for six weeks versus matching placebo three times a week for six weeks. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Azithromycin |
| Primary outcome measure(s) |
Bronchial reactivity (the dose of methacholine producing a 20 percent fall in FEV1 [PD20 methacholine]). |
| Key secondary outcome measure(s) |
1. Number of exacerbations requiring treatment with oral corticosteroids |
| Completion date | 01/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Non-smoking subjects 2. Aged 16 to 80 years, either sex 3. Refractory asthma, forced expiratory volume in one second (FEV1) greater than 50% predicted and greater than 1L and measurable airway responsiveness to methacholine challenge Refractory asthma will be defined as an FEV1/forced vital capacity (FVC) ratio less than 70% with evidence of poor asthma control in terms of regular night-time awakening (greater than 2/week) or more than four puffs of relief medication/day (greater than twice/week) requiring repeated (two or more per year) courses of oral corticosteroids despite treatment with high dose inhaled corticosteroids (at least 1000 µg beclomethasone or equivalent) and treatment with, or a previous unsuccessful trial of, a long-acting beta-agonist or leukotriene antagonist. |
| Key exclusion criteria | 1. Poor compliance with usual asthma treatment 2. Pregnancy 3. Inadequate contraception or lactation 4. Active smoking or smoking history in excess of 20 pack years 5. A clinical diagnosis of allergic bronchopulmonary aspergillosis or significant bronchiectasis 6. Other major co-morbidity including abnormal liver function tests or medication known to interact with azithromycin |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 01/07/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
NG5 1PB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/06/2016: No publications found, verifying study status with principal investigator.
