Bronchiectasis and long term Azithromycin (AZM) Treatment: a randomised placebo-controlled trial studying disease modifying effects of immunomodulating treatment
- Conditions
- BRONCHIECTASISCHRONIC BRONCHITIS10024970
- Registration Number
- NL-OMON30795
- Lead Sponsor
- Medisch Centrum Alkmaar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 90
•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.
•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
human DNAase inhalation solution, or high dose ibuprofen within 30 dagen
of screening.
•Other research medication started 2 months prior to inclusion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method