Clinical trial NCT02205242: BACE Trial Substudy 1 - PROactive Substudy
Official title: BACE Trial - Physical Activity as a Crucial Patient Reported Outcome in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: AECOPD
Chronic Obstructive Pulmonary Disease
Acute exacerbation
Hospitalization
Azithromycin
Macrolides
Randomized Controlled Trial
Placebo
Physical Activity
PRO-Active
Activity Monitor
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Pro-Active Medical Pty Ltd
First posted: 2014-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 cardiovascular and metabolic morbidity and is one of the strongest predictors of mortality in COPD. Apart from potential direct effects of the intervention on treatment failure and symptoms, positive effects on physical activity may offer considerable benefits in the long run.

Randomized patients that are willing to participate in the sub-study will be monitored for activity by validated and easy-to-wear portable devices (Dynaport®). This activity monitor was recently thoroughly validated for use in COPD by the Pro-Active consortium and will be used at the baseline, 3 months and 9 months visit. We hypothesize that with a positive medical intervention, differences in recovery of physical activity will be appreciated.

Patients will follow the standard protocol but will also wear the activity monitor for 7 days post discharge from hospital (at investigator discretion), at day 90 (end of treatment) and at day 270 (end of follow-up). This device is not only registering physical activity for 7 days but is also coupled to a standardized and patient-validated questionnaire on physical activities which needs to be filled out at day 8 to cover a recall period of 7 (monitored) days.

Patient will have to give informed consent for the additional measures that are related to the activity sub-study. However, individual patients can still opt out for these tests (sub-study) and only participate in the medical intervention study (main study).

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At discharge from hospital (0 months) and 3 months after start study drug intake
Secondary outcomes:
measure: Key secondary endpoint: Different change in physical activity (total amount of steps) at 3 months between placebo and azithromycin arm
timeFrame: 0 and 3 months
measure: Different change in physical activity (total amount of steps) at 9 months between placebo and azithromycin arm
timeFrame: at baseline and 9 months
measure: 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
timeFrame: baseline, 3 and 9 months
measure: Difference in Physical Activity (TSMVA) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 3 months after randomisation
timeFrame: At discharge from hospital (0 months) and 3 months after start study drug intake
Other outcomes:
measure: Exploratory endpoint: sensitivity analysis of primary and secondary endpoints in subgroups
timeFrame: at 0, 3 and 9 months
Locations:
city: Brussel
country: Belgium
facility: St. Pieterziekenhuis
state: Brussels Hoofdstedelijk Gewest
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
state: Vlaanderen
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
state: Vlaanderen
city: Gent
country: Belgium
facility: UZ Gent
state: Vlaanderen
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Vlaanderen
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
state: Vlaanderen
Study officials:
affiliation: KU Leuven
name: Wim Janssens, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: