The AMAZES Study: Asthma and Macrolides: the Azithromycin Efficacy and Safety Study

A large-scale, multicentre, double-blind, placebo controlled randomised trial to compare the efficacy (and safety) of the addition of oral low dose azithromycin for 48 weeks with fixed dose maintenance therapy on the incidence of asthma exacerbations and clinical asthma status in people with persistent asthma

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000197235

Acronym

AMAZES

Enrollment

420

Registered

2009-04-20

Start date

2009-06-29

Completion date

2015-01-28

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Certain types of asthmatics do not respond well to usual medications. It is likely that this is due to the type of inflammatory cells found in the airways. Asthmatics with low levels of eosinophils and high levels of neutrophils may respond better if treated with a class of antibiotics called macrolides. Long-term use of macrolides helps people with a variety of types of inflammation in the lung. As yet, it is unknown whether this will help in asthmatics. The main purpose of this study is to see whether taking two Azithromycin (a macrolide) tablets three times per week for 48 weeks will help people with asthma. It is hypothesised that taking the Azithromycin will reduce the number of asthma exacerbations (or 'attacks'), decrease the general daily symptoms experienced and improve health status.

Interventions

Azithromycin 500mg (2 x 250mg tablets to be administered by the oral route) three times weekly for 48 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Symptomatic stable asthma [ACQ(6) > 0.75], confirmed variable airflow obstruction, maintenance combination therapy

Exclusion criteria

Forced expiratory volume in 1 second (FEV1) < 40% predicted. Hypersensitivity to macrolides. Other respiratory disease. Taking macrolide, tetracycline, antibiotic or oral corticosteroid in preceeding month. Taking antacid treatment. Taking medication that prolongs heart's corrected QT interval (QTc). QTc prolongation > 0.44s. Existing ECG abnormalities that may lead to arrythmias. Taking medication that will interact with azithromycin in regard to rhabdomyolosis. Current smoking (or having quit within 1 year of study entry). Significant smoking related airspace disease. Cold or respiratory tract infection within 4 weeks of study entry. Pregnancy, breast feeding, possibility of becoming pregnant (unwilling to use additional form of contraception, besides contraceptive pill, during first 2 months of treatment). Impaired liver function. Ocular, abdominal, chest or brain surgery within 3 months prior to study entry. Lung cancer or other blood, lymphatic or solid organ malignancy. Cerebral, aortic or abdominal aneurysm. Inability to attend study visits. Participation in another investigative drug study within 4 weeks of study entry.

Outcome results