Bronchiectasis and Long Term Azithromycin Treatment

Inflammation Clinical Trial

— BAT  

Official title:

Bronchiectasis and Long Term Azithromycin Treatment: A Randomised Placebo-controlled Trial Studying Disease Modifying Effects of Immunomodulating Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415350
• Other study ID #: BAT-2006-MCA1
• Secondary ID: BAT-2006
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: December 2010

Study information

• Verified date: May 2020
• Source: Medical Center Alkmaar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis
• Inflammation

Intervention

Drug:
• Azithromycin
Azithromycin Tablet 250 mg daily

Other:
• Placebo
Placebo tablet 1 daily

Locations

Country	Name	City	State
Netherlands	Alkmaar Medical Center	Alkmaar	N-H
Netherlands	AMC	Amsterdam
Netherlands	St Lucas Andreas Ziekenhuis	Amsterdam
Netherlands	Rode Kruis Ziekenhuis	Beverwijk
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	U.L.C. Dekkerswald	Groesbeek
Netherlands	University Hospital Groningen (UMCG)	Groningen
Netherlands	Atrium Medisch Centrum	Heerlen
Netherlands	Tergooi Ziekenhuizen	Hilversum
Netherlands	Spaarne Ziekenhuis	Hoofddorp
Netherlands	MC Leeuwarden	Leeuwarden
Netherlands	Antonius Ziekenhuis	Nieuwegein
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	Diakonessenhuis	Utrecht
Netherlands	Viecuri MC	Venlo
Netherlands	Isala Klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
W.G.Boersma

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis?		1 year
Primary	Does treatment with AZM increase lung function parameters (? FEV1, ? FVC )?		1 year
Secondary	Is there any improvement in symptom score during treatment with AZM?		1 year
Secondary	What is the effect of AZM on bacterial colonisation?		1 year
Secondary	Does treatment with AZM reduce inflammatory parameters?		1 year
Secondary	Does treatment with AZM change the quality of life?		1 year
Secondary	Is there any differences in adverse events between AZM and placebo treatment?		1 year