Condition category
Respiratory
Date applied
23/10/2008
Date assigned
23/01/2009
Last edited
20/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nottingham.ac.uk/

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

Publication citations

Additional files

Editorial Notes

20/06/2016: No publications found, verifying study status with principal investigator.