BACE Trial Substudy 1 - PROactive Substudy (PROactive)
BACE Trial - Physical Activity as a Crucial Patient Reported Outcome in COPD
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
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Brussels Hoofdstedelijk Gewest
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Brussel, Brussels Hoofdstedelijk Gewest, Belgien, 1000
- St. Pieterziekenhuis
-
-
Vlaanderen
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Antwerpen, Vlaanderen, Belgien, 2020
- ZNA Middelheim
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Bonheiden, Vlaanderen, Belgien, 2820
- Imelda Ziekenhuis
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Gent, Vlaanderen, Belgien, 9000
- UZ Gent
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Hasselt, Vlaanderen, Belgien, 3500
- Jessa Ziekenhuis
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Leuven, Vlaanderen, Belgien, 3000
- UZ Gasthuisberg
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Azithromycin
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 |
Från dag 1 till och med dag 3: 500 mg azitromycin eller placebo PO en gång dagligen Från dag 4 till och med dag 90: 250 mg azitromycin eller placebo PO en gång varannan dag
Andra namn:
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
Andra namn:
|
|
Placebo-jämförare: Placebo
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 |
Andra namn:
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: At discharge from hospital (0 months) and 3 months after start study drug intake
|
Physical activity will be quantified as Total amount of steps
|
At discharge from hospital (0 months) and 3 months after start study drug intake
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Key secondary endpoint: Different change in physical activity (total amount of steps) at 3 months between placebo and azithromycin arm
Tidsram: 0 and 3 months
|
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
|
|
Different change in physical activity (total amount of steps) at 9 months between placebo and azithromycin arm
Tidsram: at baseline and 9 months
|
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
Tidsram: baseline, 3 and 9 months
|
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
Tidsram: At discharge from hospital (0 months) and 3 months after start study drug intake
|
Physical activity will be specified for:
|
At discharge from hospital (0 months) and 3 months after start study drug intake
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Exploratory endpoint: sensitivity analysis of primary and secondary endpoints in subgroups
Tidsram: at 0, 3 and 9 months
|
|
at 0, 3 and 9 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Wim Janssens, MD PhD, KU Leuven
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- s55829 - PROactive Substudy
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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