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
  Purpose

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.


Condition Intervention Phase
Bronchiectasis
Inflammation
Drug: Azithromycin
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bronchiectasis and Long Term Azithromycin Treatment: A Randomised Placebo-controlled Trial Studying Disease Modifying Effects of Immunomodulating Treatment

Resource links provided by NLM:


Further study details as provided by Medical Center Alkmaar:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 72
Study Start Date: April 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Azithromycin treatment 1 Drug: Azithromycin
Azithromycin Tablet 250 mg daily
Placebo Comparator: Placebo 2 Other: Placebo
Placebo tablet 1 daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415350

Locations
Netherlands
Alkmaar Medical Center
Alkmaar, N-H, Netherlands, 1800AM
St Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
AMC
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, Netherlands
Sponsors and Collaborators
Medical Center Alkmaar
Investigators
Study Director: W.G. Boersma, MD,PHD Medical Center Alkmaar, dep. Pulmomary Diseases
  More Information

No publications provided by Medical Center Alkmaar

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: W.G. Boersma, Alkmaar Medical Center
ClinicalTrials.gov Identifier: NCT00415350     History of Changes
Other Study ID Numbers: BAT-2006-MCA1, BAT-2006
Study First Received: December 21, 2006
Last Updated: March 16, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Center Alkmaar:
Bronchiectasis
Macrolide
Azithromycin
Antibiotic prophylaxis
Immunomodulation
Inflammation
Lung function
Sputum
Bacterial colonization

Additional relevant MeSH terms:
Bronchiectasis
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Pathologic Processes
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014