Contact information
Type
Scientific
Primary contact
Dr Tim Harrison
ORCID ID
Contact details
Respiratory Medicine
Clinical Sciences Building
City Hospital site
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 823 1247
tim.harrison@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Final version 1.1
Study information
Scientific title
MACrolides in Refractory Asthma: a single-centre randomised placebo-controlled two-period cross-over trial
Acronym
MACRA
Study hypothesis
Azithromycin improves bronchial hyper-responsiveness in patients with refractory asthma.
Ethics approval
Nottingham Research Ethics Committee 2, 06/06/2008, ref: 08/H0408/64
Study design
Single-centre randomised two-period cross-over placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Azithromycin
Primary outcome measures
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 trial start date
01/01/2009
Overall trial end date
01/07/2010
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
01/01/2009
Recruitment end date
01/07/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Nottingham
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Head of Research Grants and Contracts
Research Innovation Services
King's Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Nottingham (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
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