AZithromycin Against pLacebo in Exacerbations of Asthma

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Zithromax; Drug: Placebo

• Registration Number: NCT01444469
• Lead Sponsor: Imperial College London

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 Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-09-29
• Study First Posted: 2011-09-30
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithromycin (Zithromax)	Zithromax	500 mg of azithromycin (2×250mg capsules)
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Diary card summary symptom score	10 days after randomisation	Symptoms include wheezing, breathlessness and coughing assessed at 10 days after randomisation.

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed by acute asthma QolQ (Juniper)	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	From Visit 1 (day 1) to Visit 4 (day 42)
Pulmonary Function tests	5 & 10 days post randomisation	Pulmonary function tests include: FEV1, FVC, FEV1/FVC ratio, PEF, FEF25-75% and FEF50%

Trial Locations

Locations (14)

Barnsley Hospital NHS Foundation; 🇬🇧 Barnsley, England, United Kingdom

Countess of Chester Hospital NHS Foundation Trust; 🇬🇧 Liverpool, England, United Kingdom

Surrey & Sussex Healthcare NHS Trust; 🇬🇧 Redhill, England, United Kingdom

Heart of England NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Blackpool Teaching Hospitals NHS Foundation Trust; 🇬🇧 Blackpool, United Kingdom

University of Glasgow; 🇬🇧 Glasgow, United Kingdom

University Hospitals of Leicester NHS Foundation Trust; 🇬🇧 Leicester, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

University Hospital of South Manchester Foundation Trust; 🇬🇧 Manchester, United Kingdom

Newcastle upon Tyne Hospitals NHS Foundation Trust; 🇬🇧 Newcastle, United Kingdom

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