Status:
COMPLETED
BACE Trial Substudy 2 - FarmEc Substudy
Lead Sponsor:
Wim Janssens
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A second sub-analysis of the BACE trial will include a detailed cost-effectiveness study.
Detailed Description
Our multicenter randomized trial executed in one country will provide an excellent tool for more precise health economic assessments. In a first approach, rough estimates on savings of direct costs in...
Eligibility Criteria
Inclusion
- Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test)
- Smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc.)
- Current hospitalization for potential infectious AECOPD treated with standard therapy
- History of at least one exacerbation during the last year (prior to the current hospital admission) for which systemic steroids and/or antibiotics were taken
- ECG at admission
Exclusion
- Mechanical or non-invasive ventilation at moment of randomization (D1)
- Long QT interval on ECG (QTc \> 450msec for males or \> 470msec for females)
- History of life-threatening arrhythmias
- Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before start of study drug
- Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission
- Drugs with high risk for long QT interval and torsade de pointes (amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides)
- Documented uncorrected severe hypokalemia (K+ \< 3.0 mmol/L) or hypomagnesemia (Mg2+ \< 0.5 mmol/L)
- Chronic systemic steroids (\> 4 mg methylprednisolone /day for ≥ 2 months)
- Actual use of macrolides for at least 2 weeks
- Allergy to macrolides
- Active cancer treatment
- Life expectancy \< 3 months
- Pregnant or breast-feeding subjects. Woman of childbearing potential must have a pregnancy test performed and a negative result must be documented before start of treatment
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT02205255
Start Date
August 1 2014
End Date
April 1 2020
Last Update
April 8 2020
Active Locations (20)
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1
UZ Brussel
Brussels, Brussel Hoofdstedelijk Gewest, Belgium, 1090
2
St. Pieterziekenhuis
Brussels, Brussels Capital, Belgium, 1000
3
ZNA Middelheim
Antwerp, Flanders, Belgium, 2020
4
St. Augustinus Ziekenhuis
Antwerp, Flanders, Belgium, 2610