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Clinical Trials/NCT01444469
NCT01444469
Completed
Phase 4

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

Imperial College London14 sites in 1 country199 target enrollmentSeptember 2011
ConditionsAsthma
InterventionsZithromaxPlacebo

Overview

Phase
Phase 4
Intervention
Zithromax
Conditions
Asthma
Sponsor
Imperial College London
Enrollment
199
Locations
14
Primary Endpoint
Diary card summary symptom score
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
June 2014
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Azithromycin (Zithromax)

500 mg of azithromycin (2×250mg capsules)

Intervention: Zithromax

Placebo

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Diary card summary symptom score

Time Frame: 10 days after randomisation

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

Secondary Outcomes

  • Time to 50% reduction in symptom score(From Visit 1 (day 1) to Visit 4 (day 42))
  • Quality of life assessed by acute asthma QolQ (Juniper)(5 & 10 days post randomisation)
  • Pulmonary Function tests(5 & 10 days post randomisation)

Study Sites (14)

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