Status:
COMPLETED
BACE Trial Substudy 1 - PROactive Substudy
Lead Sponsor:
Wim Janssens
Collaborating Sponsors:
Pro-Active Medical Pty Ltd
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A first sub-analysis of the BACE trial will address physical activity levels in a subgroup of the intervention study with portable validated activity monitors.
Detailed Description
Physical activity is strongly reduced with exacerbations and failure to increase physical activity is associated with relapse. In addition, physical inactivity is known to be associated with cardiovas...
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 :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02205242
Start Date
September 1 2014
End Date
April 1 2020
Last Update
April 8 2020
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Pieterziekenhuis
Brussels, Brussels Capital, Belgium, 1000
2
ZNA Middelheim
Antwerp, Flanders, Belgium, 2020
3
Imelda Ziekenhuis
Bonheiden, Flanders, Belgium, 2820
4
UZ Gent
Ghent, Flanders, Belgium, 9000