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Bronchiectasis and Long Term Azithromycin Treatment (BAT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Medical Center Alkmaar.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medical Center Alkmaar
ClinicalTrials.gov Identifier:
NCT00415350
First received: December 21, 2006
Last updated: March 16, 2010
Last verified: September 2009

December 21, 2006
March 16, 2010
April 2008
December 2009   (final data collection date for primary outcome measure)
  • Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis?
  • Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )?
Complete list of historical versions of study NCT00415350 on ClinicalTrials.gov Archive Site
  • Is there any improvement in symptom score during treatment with AZM? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • What is the effect of AZM on bacterial colonisation? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Does treatment with AZM reduce inflammatory parameters? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Does treatment with AZM change the quality of life? [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Is there any differences in adverse events between AZM and placebo treatment? [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Is there any improvement in symptom score during treatment with AZM?
  • What is the effect of AZM on bacterial colonisation?
  • Does treament with AZM reduce inflammatory parameters?
  • Does treatment with AZM change the quality of life?
  • Is there any differences in adverse events between AZM en placebo treatment?
Not Provided
Not Provided
 
Bronchiectasis and Long Term Azithromycin Treatment
Bronchiectasis and Long Term Azithromycin Treatment: A Randomised Placebo-controlled Trial Studying Disease Modifying Effects of Immunomodulating Treatment

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bronchiectasis
  • Inflammation
  • Drug: Azithromycin
    Azithromycin Tablet 250 mg daily
  • Other: Placebo
    Placebo tablet 1 daily
  • Active Comparator: Azithromycin treatment 1
    Intervention: Drug: Azithromycin
  • Placebo Comparator: Placebo 2
    Intervention: Other: Placebo
Altenburg J, de Graaff CS, Stienstra Y, Sloos JH, van Haren EH, Koppers RJ, van der Werf TS, Boersma WG. Effect of azithromycin maintenance treatment on infectious exacerbations among patients with non-cystic fibrosis bronchiectasis: the BAT randomized controlled trial. JAMA. 2013 Mar 27;309(12):1251-9. doi: 10.1001/jama.2013.1937.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
72
December 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00415350
BAT-2006-MCA1, BAT-2006
No
W.G. Boersma, Alkmaar Medical Center
Medical Center Alkmaar
Not Provided
Study Director: W.G. Boersma, MD,PHD Medical Center Alkmaar, dep. Pulmomary Diseases
Medical Center Alkmaar
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP