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| Name | Class |
|---|---|
| Pro-Active Medical Pty Ltd | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Experimental | 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 |
|
| Placebo | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory endpoint: sensitivity analysis of primary and secondary endpoints in subgroups |
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wim Janssens, MD PhD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Pieterziekenhuis | Brussels | Brussels Capital | 1000 | Belgium | ||
| ZNA Middelheim |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
| Dynaport® | Device | Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months |
|
|
| Placebo | Drug |
|
|
| 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 |
| 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:
| 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:
| At discharge from hospital (0 months) and 3 months after start study drug intake |
| at 0, 3 and 9 months |
| Antwerp |
| Flanders |
| 2020 |
| Belgium |
| Imelda Ziekenhuis | Bonheiden | Flanders | 2820 | Belgium |
| UZ Gent | Ghent | Flanders | 9000 | Belgium |
| Jessa Ziekenhuis | Hasselt | Flanders | 3500 | Belgium |
| UZ Gasthuisberg | Leuven | Flanders | 3000 | Belgium |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Organic Chemicals |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |