A Phase 3 interventional study of Azithromycin and Dynaport® in Chronic Obstructive Pulmonary Disease, sponsored by Wim Janssens. Completed at 6 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-08.
Sponsored by Wim Janssens · Phase 3, Interventional, and Treatment
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.
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).
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
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Exclusion Criteria:
N = 250 From day 1 up to and including day 3: 500 mg azithromycin PO once a day From day 4 up to and including day 90: 250 mg azithromycin PO once every 2 days N= 30 During 7 days post discharge from hospital (0 months), 3 months and 9 months, the patient will wear the Dynaport® which will register the patient's physical activity
Drug: Azithromycin · Device: Dynaport®
N = 250 From day 1 up to and including day 3: 500 mg placebo PO once a day From day 4 up to and including day 90: 250 mg placebo PO once every 2 days N= 30 During 7 days post discharge from hospital (0 months), 3 months and 9 months, the patient will wear the Dynaport® which will register the patient's physical activity
Device: Dynaport® · Drug: Placebo
From day 1 up to and including day 3: 500 mg azithromycin or placebo PO once a day From day 4 up to and including day 90: 250 mg azithromycin or placebo PO once every 2 days
Also known as: Azitromcyine CF, ATC code: J01FA10
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
Also known as: Activity monitor
Also known as: Inactive substance
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
Time frame: At discharge from hospital (0 months) and 3 months after start study drug intake
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
Time frame: 0 and 3 months
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
Time frame: at baseline and 9 months
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: 1. Total amount of steps 2. Total time spent in moderate to intense physical activity 3. Sedentary Time (Lying-Sitting) and Time Active (Standing-Locomotion-Shuffeling)
Time frame: baseline, 3 and 9 months
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: 1. Total time spent in moderate to intense physical activity 2. Sedentary Time (Lying-Sitting) and Time Active (Standing-Locomotion-Shuffeling)
Time frame: At discharge from hospital (0 months) and 3 months after start study drug intake
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
Time frame: at 0, 3 and 9 months
Plan to share: No
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin
Pulmonary Disease, Chronic Obstructive →
Wim Janssens