Bronchiectasis and Long Term Azithromycin Treatment

Phase 3

Completed

• Conditions: Bronchiectasis; Inflammation
• Interventions: Other: Placebo; Drug: Azithromycin

• Registration Number: NCT00415350
• Lead Sponsor: W.G.Boersma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-21
• Study First Submitted QC: 2006-12-21
• Study First Posted: 2006-12-22
• Study Start: 2008-04
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-26
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo 2	Placebo	-
Azithromycin treatment 1	Azithromycin	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (16)

Viecuri MC; 🇳🇱 Venlo, Netherlands

U.L.C. Dekkerswald; 🇳🇱 Groesbeek, Netherlands

Tergooi Ziekenhuizen; 🇳🇱 Hilversum, Netherlands

Atrium Medisch Centrum; 🇳🇱 Heerlen, Netherlands

Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

AMC; 🇳🇱 Amsterdam, Netherlands

Alkmaar Medical Center; 🇳🇱 Alkmaar, N-H, Netherlands

University Hospital Groningen (UMCG); 🇳🇱 Groningen, Netherlands

Spaarne Ziekenhuis; 🇳🇱 Hoofddorp, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Deventer Ziekenhuis; 🇳🇱 Deventer, Netherlands

MC Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

St Lucas Andreas Ziekenhuis; 🇳🇱 Amsterdam, Netherlands

Rode Kruis Ziekenhuis; 🇳🇱 Beverwijk, Netherlands

Diakonessenhuis; 🇳🇱 Utrecht, Netherlands

Isala Klinieken; 🇳🇱 Zwolle, Netherlands