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Clinical trial

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

Read time: 3 mins
Last updated:29th Jun 2009
Identifier: ACTRN12609000197235

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.

Study type: Interventional
Description of intervention(s) / exposure: Azithromycin 500mg (2 x 250mg tablets to be administered by the oral route) three times weekly for 48 weeks
Public title: The AMAZES Study: Asthma and Macrolides: the Azithromycin Efficacy and Safety Study
Scientific title: 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
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Masking / blinding: Blinded (masking used)
Phase: Phase 3
Type of endpoint(s): Safety/efficacy

Category Value
Date last updated at source 2016-03-10
Study type(s) Interventional
Expected enrolment 420
Study start date 2009-06-29

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