NL-OMON30795
Recruiting
Phase 3
Bronchiectasis and long term Azithromycin (AZM) Treatment: a randomised placebo-controlled trial studying disease modifying effects of immunomodulating treatment - The BAT trial: AZM versus placebo in bronchiectasis
Medisch Centrum Alkmaar0 sites90 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medisch Centrum Alkmaar
- Enrollment
- 90
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18 \>\= years
- •Bronchiectasis diagnosed by plain bronchography or high resolution computer tomography.
- •Minimal 4 lower respiratory tract infection (LRTI) treated with oral/IV antibiotics in the year preceeding the study inclusion.
- •The presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum.
- •Three sputum cultures with either P.aeruginosa or H. influenzae in the preceeding year.
- •Informed consent.
Exclusion Criteria
- •Previous ( \>\= 6 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 orale or IV corticosteroids (\>\= 30 mg prednisolone/daily) within 30 days
- •of screening.
- •Initiation of tobramycin/colimycin solution for inhalation, recombinant
Outcomes
Primary Outcomes
Not specified
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