Macrolides in refractory asthma
| ISRCTN | ISRCTN93221282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93221282 |
| Secondary identifying numbers | Final version 1.1 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Tim Harrison
Scientific
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
| Study design | Single-centre randomised two-period cross-over placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| 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 | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Azithromycin |
| Primary outcome measure | Bronchial reactivity (the dose of methacholine producing a 20 percent fall in FEV1 [PD20 methacholine]). Primary and secondary outcomes measured at the end of each 6 week treatment period. |
| Secondary outcome measures | 1. Number of exacerbations requiring treatment with oral corticosteroids 2. Number of exacerbations requiring an increase in asthma therapy 3. Total dose of oral corticosteroids taken during the treatment period 4. Inhaled corticosteroid use 5. Reliever medication use 6. FEV1 7. Peak expiratory flow (PEF) 8. Exhaled nitric oxide 9. Blood and sputum differential cell counts 10. Asthma symptoms 11. Asthma Control Questionnaire (ACQ) score 12. Asthma Quality of Life Questionnaire (AQLQ) 13. Liver function tests 14. Adverse effects 15. Participants' views on study design, acceptability and issues that would be important to consider when designing a larger trial Primary and secondary outcomes measured at the end of each 6 week treatment period. |
| Overall study start date | 01/01/2009 |
| Completion date | 01/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
University of Nottingham
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Head of Research Grants and Contracts
Research Innovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
University/education
University of Nottingham (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
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 |
Editorial Notes
20/06/2016: No publications found, verifying study status with principal investigator.
