Chronic Obstructive Pulmonary Disease Clinical Trial
— PROactiveOfficial title:
BACE Trial - Physical Activity as a Crucial Patient Reported Outcome in COPD
Verified date | April 2020 |
Source | KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | April 2020 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | ZNA Middelheim | Antwerpen | Vlaanderen |
Belgium | Imelda Ziekenhuis | Bonheiden | Vlaanderen |
Belgium | St. Pieterziekenhuis | Brussel | Brussels Hoofdstedelijk Gewest |
Belgium | UZ Gent | Gent | Vlaanderen |
Belgium | Jessa Ziekenhuis | Hasselt | Vlaanderen |
Belgium | UZ Gasthuisberg | Leuven | Vlaanderen |
Lead Sponsor | Collaborator |
---|---|
Wim Janssens | Pro-Active Medical Pty Ltd |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory endpoint: sensitivity analysis of primary and secondary endpoints in subgroups | Male vs female Smoker vs ex-smoker (stopped smoking > 6 months) GOLD A, B vs GOLD C vs GOLD D Former GOLD I, II vs III vs IV High CRP (> 50 mg/dL) vs low CRP (< 50 mg/dL) Age < 60 years vs age 60 - 70 years vs age > 70 years Anthonissen I vs Anthonissen II vs Anthonissen III at admission ICS use vs no ICS use |
at 0, 3 and 9 months | |
Primary | Difference in Physical Activity (total amount of steps) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 3 months after randomisation | Physical activity will be quantified as Total amount of steps | At discharge from hospital (0 months) and 3 months after start study drug intake | |
Secondary | Key secondary endpoint: Different change in physical activity (total amount of steps) at 3 months between placebo and azithromycin arm | Difference between placebo and azithromycin arm in physical activity changes registered by the Dynaport® during 7 days at discharge from hospital (0 months) and at 3 months | 0 and 3 months | |
Secondary | Different change in physical activity (total amount of steps) at 9 months between placebo and azithromycin arm | Difference between placebo and azithromycin arm in physical activity changes registered by the Dynaport® during 7 days at discharge from hospital (0 months) and at 9 months | at baseline and 9 months | |
Secondary | Difference in Physical Activity (TSMVA) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 9 months, or between 3 months and 9 months after randomisation | Physical activity will be specified for: Total amount of steps Total time spent in moderate to intense physical activity Sedentary Time (Lying-Sitting) and Time Active (Standing-Locomotion-Shuffeling) |
baseline, 3 and 9 months | |
Secondary | Difference in Physical Activity (TSMVA) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 3 months after randomisation | Physical activity will be specified for: Total time spent in moderate to intense physical activity Sedentary Time (Lying-Sitting) and Time Active (Standing-Locomotion-Shuffeling) |
At discharge from hospital (0 months) and 3 months after start study drug intake |
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