Status:
COMPLETED
Bronchiectasis and Long Term Azithromycin Treatment
Lead Sponsor:
W.G.Boersma
Conditions:
Bronchiectasis
Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00415350
Start Date
April 1 2008
End Date
December 1 2010
Last Update
May 28 2020
Active Locations (16)
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1
Alkmaar Medical Center
Alkmaar, N-H, Netherlands, 1800AM
2
AMC
Amsterdam, Netherlands
3
St Lucas Andreas Ziekenhuis
Amsterdam, Netherlands
4
Rode Kruis Ziekenhuis
Beverwijk, Netherlands