Overview

This trial is active, not recruiting.

Conditions bronchiectasis, inflammation
Treatments azithromycin, placebo
Phase phase 3
Sponsor Medical Center Alkmaar
Start date April 2008
End date December 2009
Trial size 72 participants
Trial identifier NCT00415350, BAT-2006, BAT-2006-MCA1

Summary

1. SUMMARY

Rationale: Patients with bronchiectasis often experience lower respiratory tract infections with progression of symptoms and decline in quality of life. Macrolides, as has been shown in panbronchiolitis and cystic fibrosis, may break or weaken the link between infection and inflammation resulting in an improvement of symptoms. Also the number of exacerbations may lowered.

Objective: A reduction in number of infective exacerbations and improvement in lung function by AZT treatment are the primary objectives. Secondary objectives that will be evaluated are: symptoms score, quality of life, inflammatory parameters, bacterial colonisation, and adverse events.

Study design: Randomised double blind multicenter study in the Netherlands. Patients will be stratified for colonisation with P.aeruginosa.

Study population: Patients with bronchiectasis demonstrated by high-resolution computed tomography (HR-CT) scan or bronchography.

Intervention: Patients receive Azithromycin 250mg(p.o.) once daily or placebo.

Main study parameters/endpoints: Reduction in number exacerbations, defined as increase symptoms such as dyspnoea, coughing, and sputum production for which a course of prednisolone and/or antibiotic is needed. Change in lung function parameters (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC]) measured by spirometry is the other primary endpoint.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of participating in this study is low. Laboratory, radiographic examinations, and pulmonary function tests are commonly used as diagnostic procedures during outpatients visits and during exacerbations. Adverse effects in maintenance treatment with AZT are usually mild and mainly gastrointestinal. Sometimes rash and abnormal liver function tests are observed. A better quality of life will probably be the beneficial effect of long term treatment with AZT. This will be achieved by a reduction in respiratory and non-respiratory symptoms and number of exacerbations.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
azithromycin
Azithromycin Tablet 250 mg daily
(Placebo Comparator)
placebo
Placebo tablet 1 daily

Primary Outcomes

Measure
Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis?
time frame: 1 year
Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )?
time frame: 1 year

Secondary Outcomes

Measure
Is there any improvement in symptom score during treatment with AZM?
time frame: 1 year
What is the effect of AZM on bacterial colonisation?
time frame: 1 year
Does treatment with AZM reduce inflammatory parameters?
time frame: 1 year
Does treatment with AZM change the quality of life?
time frame: 1 year
Is there any differences in adverse events between AZM and placebo treatment?
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients aged 18 ≥ years - Bronchiectasis diagnosed by plain bronchography or high resolution computer tomography. - Minimal 3 lower respiratory tract infections (LRTI) treated with oral/intravenous (IV) antibiotics in the year preceding the study inclusion. - The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum. - At least one positive sputum culture in the preceding year. - Informed consent Exclusion Criteria: - Previous ( ≥ 4 weeks) prolonged macrolide therapy. - Pregnant or lactating women. - Allergy to macrolides. - Intolerance to macrolides. - Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal). - Use of antibiotics within 14 days of screening. - Use of oral or IV corticosteroids (≥ 30 mg prednisolone/daily) within 30 days of screening. - Other research medication started 2 months prior to inclusion.

Additional Information

Official title Bronchiectasis and Long Term Azithromycin Treatment: A Randomised Placebo-controlled Trial Studying Disease Modifying Effects of Immunomodulating Treatment
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by Medical Center Alkmaar.