AZithromycin Against pLacebo in Exacerbations of Asthma (AZALEA)

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Oral Azithromycin (500 Mg OD) as a Supplement to Standard Care for Adult Patients with Acute Exacerbations of Asthma

• IRAS ID

  71792

• Contact name

  Sebastian Johnston

• Sponsor organisation

  Imperial College, London

• Eudract number

  2011-001093-26

• ISRCTN Number

  not sent

• Research summary

  Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering and occasionally death. Current treatments for asthma attacks are not very effective and new and better treatments are urgently needed. Viral respiratory infections often cause asthma attacks and bacterial respiratory pathogens (disease producing micro-organisms) have also been associated with asthma attacks. However, current guidelines recommend antibiotic therapy should NOT routinely be given as the role for bacteria is uncertain. We have shown previously that adults experiencing an asthma attack showed a significantly greater reduction in symptoms, improvement in lung function (both 50-100% greater) and faster recovery (5 days vs 8) when given a particular antibiotic (Telithromycin) compared to placebo ('dummy' treatment). This treatment had a clear benefit, however safety concerns have limited the use of Telithromycin to life-threatening infections. We would therefore like to investigate whether or not Azithromycin, which is a safe and well tolerated alternative antibiotic, similar to Telithromycin and that has been used for many years in the treatment of respiratory disease, might be of benefit in asthma exacerbations. This data will provide a clear evidence base for future guidelines. In addition we would like to study 1) how frequently bacteria are detected in asthma exacerbations and 2) the mechanisms by which antibiotics improve recovery from an asthma exacerbation in order to have a clearer understanding of how exacerbations are triggered and therefore how to treat them. We hope this work will also help identify who may benefit most from such treatment.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  11/LO/0779

• Date of REC Opinion

  15 Jun 2011

• REC opinion

  Favourable Opinion