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BACE Trial Substudy 1 - PROactive Substudy (PROactive)

7. april 2020 opdateret af: Wim Janssens

BACE Trial - Physical Activity as a Crucial Patient Reported Outcome in COPD

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
    • Brussels Hoofdstedelijk Gewest
      • Brussel, Brussels Hoofdstedelijk Gewest, Belgien, 1000
        • St. Pieterziekenhuis
    • Vlaanderen
      • Antwerpen, Vlaanderen, Belgien, 2020
        • ZNA Middelheim
      • Bonheiden, Vlaanderen, Belgien, 2820
        • Imelda Ziekenhuis
      • Gent, Vlaanderen, Belgien, 9000
        • UZ Gent
      • Hasselt, Vlaanderen, Belgien, 3500
        • Jessa Ziekenhuis
      • Leuven, Vlaanderen, Belgien, 3000
        • Uz Gasthuisberg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Medicin: Azithromycin
Fra dag 1 til og med dag 3: 500 mg azithromycin eller placebo PO én gang dagligt Fra dag 4 til og med dag 90: 250 mg azithromycin eller placebo PO én gang hver 2. dag
Andre navne:
  • Azitrocyin CF
  • ATC-kode: J01FA10
Enhed: Dynaport®
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
Andre navne:
  • Aktivitetsmonitor
Placebo komparator: 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
Medicin: Placebo
Andre navne:
  • Inaktivt stof
Enhed: Dynaport®
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
Andre navne:
  • Aktivitetsmonitor

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Key secondary endpoint: Different change in physical activity (total amount of steps) at 3 months between placebo and azithromycin arm
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline, 3 and 9 months

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)
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
Tidsramme: At discharge from hospital (0 months) and 3 months after start study drug intake

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)
At discharge from hospital (0 months) and 3 months after start study drug intake

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exploratory endpoint: sensitivity analysis of primary and secondary endpoints in subgroups
Tidsramme: at 0, 3 and 9 months
  • 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
at 0, 3 and 9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wim Janssens

Samarbejdspartnere

Pro-Active Medical Pty Ltd

Efterforskere

  • Ledende efterforsker: Wim Janssens, MD PhD, KU Leuven

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2014

Primær færdiggørelse (Faktiske)

1. april 2018

Studieafslutning (Faktiske)

1. april 2020

Datoer for studieregistrering

Først indsendt

22. juli 2014

Først indsendt, der opfyldte QC-kriterier

30. juli 2014

Først opslået (Skøn)

31. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • s55829 - PROactive Substudy

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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