Clinical Trial: AZithromycin Against pLacebo in Exacerbations of Asthma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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

Brief Summary: Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in asthmatic patients. Current treatments for asthma attacks are not completely effective and new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung infections have also been associated with asthma attacks. However, the role for bacteria is uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not recommend the routine use of antibiotics. The investigators would like to investigate whether or not azithromycin, which is a safe and well tolerated antibiotic (an antibacterial) that has been used for many years in the treatment of respiratory disease, might be of benefit in asthma attacks. As there is some evidence that azithromycin has anti-viral properties this may add to its benefits (antibiotics don't usually affect viruses). By looking at the effect of azithromycin on asthma attacks this will help us to show whether or not azithromycin should be recommended during an acute asthma attack in addition to the usual care that is provided to these patients as it may help them recover quicker from the exacerbation. The investigators will also be able to look at why azithromycin may be effective - if it is having an anti-bacterial and/or anti-viral effect.

Detailed Summary:
Sponsor: Imperial College London

Current Primary Outcome: Diary card summary symptom score [ Time Frame: 10 days after randomisation ]

Symptoms include wheezing, breathlessness and coughing assessed at 10 days after randomisation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life [ Time Frame: 5 & 10 days post randomisation ]
    • Health status assessed by acute asthma QolQ (Juniper)
    • Health status assessed by Mini Asthma QolQ (Juniper)
  • Time to 50% reduction in symptom score [ Time Frame: From Visit 1 (day 1) to Visit 4 (day 42) ]
  • Pulmonary Function tests [ Time Frame: 5 & 10 days post randomisation ]
    Pulmonary function tests include: FEV1, FVC, FEV1/FVC ratio, PEF, FEF25-75% and FEF50%


Original Secondary Outcome: Same as current

Information By: Imperial College London

Dates:
Date Received: September 22, 2011
Date Started: September 2011
Date Completion:
Last Updated: July 22, 2014
Last Verified: November 2013