Efficacy of Azithromycin in Treatment of Bronchiectasis

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Bronchiectasis is a chronic lung condition characterised primarily by dilatation of the airways. Only a small number of clinical studies have been conducted investigating the use of macrolides to treat non-cystic fibrosis bronchiectasis. The purpose of this study is to determine the efficacy of 12 weeks treatment with azithromycin in adult patients with non-cystic fibrosis bronchiectasis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Penang Hospital, Malaysia
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Have provided written informed consent to participate in the study in accordance with the local ethics committee regulations

• Have a confirmed diagnosis of bronchiectasis (by HRCT) Aged 18 years or over Have chronic sputum production, defined as a greater than 45 mililitres volume produced in the 1 week prior to study entry.

• Be able to perform reproducible spirometry

• Be in a relatively stable disease state in the 6 weeks prior to entry, as defined by the absence of the following: respiratory exacerbations requiring hospitalisation, change in cough and/or sputum production, new or increased hemoptysis, more than 10% weight loss, use of additional antibiotic courses

Exclusion Criteria:

• Subjects will be excluded if one or more of the following criteria occur. The subject:

Is an investigator, or an immediate family member of an investigator

• Has a confirmed diagnosis of cystic fibrosis, as evidenced by genetic analysis or a sweat test result more than 60mmol/L

• Has a primary immunodeficiency Is a pregnant or lactating female Has had a respiratory exacerbation requiring hospitalisation or additional course of antibiotics in the 6 weeks prior to study entry

• Has been prescribed or used oral steroids on any occasion for the 3 months prior to study entry.

• Has been using mucolytic agents on any occasion for the 2 months prior to study entry Has active tuberculosis

• Has an active malignancy, including melanoma (other skin carcinomas excluded)

• Has a history of significant liver disease or insufficiency Has a significant history of drug abuse (including alcohol abuse) or mental illness Has a known intolerance or allergy to macrolides

• Has been participating in another interventional drug study in the 3 months prior to enrolment into this study