BACE Trial Substudy 1 - PROactive Substudy (PROactive)
BACE Trial - Physical Activity as a Crucial Patient Reported Outcome in COPD
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Brussels Hoofdstedelijk Gewest
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Brussel, Brussels Hoofdstedelijk Gewest, Belgio, 1000
- St. Pieterziekenhuis
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Vlaanderen
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Antwerpen, Vlaanderen, Belgio, 2020
- ZNA Middelheim
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Bonheiden, Vlaanderen, Belgio, 2820
- Imelda Ziekenhuis
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Gent, Vlaanderen, Belgio, 9000
- UZ Gent
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Hasselt, Vlaanderen, Belgio, 3500
- Jessa Ziekenhuis
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Leuven, Vlaanderen, Belgio, 3000
- Uz Gasthuisberg
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
Dal giorno 1 fino al giorno 3 compreso: 500 mg di azitromicina o placebo PO una volta al giorno Dal giorno 4 fino al giorno 90 compreso: 250 mg di azitromicina o placebo PO una volta ogni 2 giorni
Altri nomi:
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
Altri nomi:
|
|
Comparatore placebo: 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 |
Altri nomi:
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: At discharge from hospital (0 months) and 3 months after start study drug intake
|
Physical activity will be quantified as Total amount of steps
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At discharge from hospital (0 months) and 3 months after start study drug intake
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Key secondary endpoint: Different change in physical activity (total amount of steps) at 3 months between placebo and azithromycin arm
Lasso di tempo: 0 and 3 months
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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
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0 and 3 months
|
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Different change in physical activity (total amount of steps) at 9 months between placebo and azithromycin arm
Lasso di tempo: at baseline and 9 months
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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
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at baseline and 9 months
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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
Lasso di tempo: baseline, 3 and 9 months
|
Physical activity will be specified for:
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baseline, 3 and 9 months
|
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Difference in Physical Activity (TSMVA) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 3 months after randomisation
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Exploratory endpoint: sensitivity analysis of primary and secondary endpoints in subgroups
Lasso di tempo: at 0, 3 and 9 months
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at 0, 3 and 9 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Wim Janssens, MD PhD, KU Leuven
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- s55829 - PROactive Substudy
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