Phase 4 N=78 Randomized Quadruple-blind Treatment

Efficacy of Azithromycin in Treatment of Bronchiectasis

Bronchiectasis

Bottom Line

View on ClinicalTrials.gov: NCT02107274 ↗

Enrolled (actual)

Serious AEs

13.2%

Results posted

Jul 2014

Primary outcome: Primary: 24 Hour Sputum Volume — 41.8; 23.6; 29.9; 26.2 gram — p=<0.01

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Azithromycin (Drug); Placebo for Azithromycin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Penang Hospital, Malaysia
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY 24 Hour Sputum Volume	41.8; 23.6; 29.9; 26.2; 30.4; 28.5	<0.01 sig
SECONDARY Health Status: St George's Respiratory Questionnaire Score	41.1; 36.4; 30.2; 39.1; 31.7; 41.1	<0.01 sig
SECONDARY Spirometry Value; Forced Expiratory Volume at 1 Second (FEV1)	1.08; 1.17; 1.09; 1.10; 1.04; 1.08	<0.01 sig
SECONDARY Spirometric Values: Forced Vital Capacity (FVC)	1.56; 1.69; 1.58; 1.60; 1.55; 1.58	<0.01 sig

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02107274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.