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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00415350 |
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Date of registration:
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21/12/2006 |
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Primary sponsor: |
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Public title:
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Bronchiectasis and Long Term Azithromycin Treatment
BAT |
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Scientific title:
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Bronchiectasis and Long Term Azithromycin Treatment: A Randomised Placebo-controlled Trial Studying Disease Modifying Effects of Immunomodulating Treatment |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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72 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00415350 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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W.G. Boersma, MD,PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Center Alkmaar, dep. Pulmomary Diseases |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bronchiectasis
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Inflammation
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Intervention(s)
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Drug: Azithromycin
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Other: Placebo
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Primary Outcome(s)
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Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis?
[Time Frame: 1 year]
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Does treatment with AZM increase lung function parameters (? FEV1, ? FVC )?
[Time Frame: 1 year]
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Secondary Outcome(s)
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Does treatment with AZM change the quality of life?
[Time Frame: 1 year]
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Does treatment with AZM reduce inflammatory parameters?
[Time Frame: 1 year]
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Is there any differences in adverse events between AZM and placebo treatment?
[Time Frame: 1 year]
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Is there any improvement in symptom score during treatment with AZM?
[Time Frame: 1 year]
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What is the effect of AZM on bacterial colonisation?
[Time Frame: 1 year]
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Secondary ID(s)
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BAT-2006
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BAT-2006-MCA1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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