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BACE Trial Substudy 1 - PROactive Substudy (PROactive)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

Azithromycin

Dynaport®

Placebo

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring AECOPD, Chronic Obstructive Pulmonary Disease, Acute exacerbation, Hospitalization, Azithromycin, Macrolides, Randomized Controlled Trial, Placebo, Physical Activity, PRO-Active, Activity Monitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Pieterziekenhuis
ZNA Middelheim
Imelda Ziekenhuis
UZ Gent
Jessa Ziekenhuis
UZ Gasthuisberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Azithromycin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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: Total amount of steps Total time spent in moderate to intense physical activity Sedentary Time (Lying-Sitting) and Time Active (Standing-Locomotion-Shuffeling)

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: Total time spent in moderate to intense physical activity Sedentary Time (Lying-Sitting) and Time Active (Standing-Locomotion-Shuffeling)

Full Information

NCT ID

NCT02205242

First Posted

July 22, 2014

Last Updated

April 7, 2020

Sponsor

Wim Janssens

Collaborators

Pro-Active Medical Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02205242

Brief Title

BACE Trial Substudy 1 - PROactive Substudy

Acronym

PROactive

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wim Janssens

Collaborators

Pro-Active Medical Pty Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

AECOPD, Chronic Obstructive Pulmonary Disease, Acute exacerbation, Hospitalization, Azithromycin, Macrolides, Randomized Controlled Trial, Placebo, Physical Activity, PRO-Active, Activity Monitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Azithromycin

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Azithromycin

Other Intervention Name(s)

Azitromcyine CF, ATC code: J01FA10

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Dynaport®

Other Intervention Name(s)

Activity monitor

Intervention Description

Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Inactive substance

Primary Outcome Measure Information:

Title

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

Description

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

Secondary Outcome Measure Information:

Title

Key secondary endpoint: Different change in physical activity (total amount of steps) at 3 months between placebo and azithromycin arm

Description

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

Title

Different change in physical activity (total amount of steps) at 9 months between placebo and azithromycin arm

Description

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

Title

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

Description

Time Frame

baseline, 3 and 9 months

Title

Difference in Physical Activity (TSMVA) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 3 months after randomisation

Description

Physical activity will be specified for: Total time spent in moderate to intense physical activity 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

Other Pre-specified Outcome Measures:

Title

Exploratory endpoint: sensitivity analysis of primary and secondary endpoints in subgroups

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wim Janssens, MD PhD

Organizational Affiliation

KU Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Pieterziekenhuis

City

Brussel

State/Province

Brussels Hoofdstedelijk Gewest

ZIP/Postal Code

1000

Country

Belgium

Facility Name

ZNA Middelheim

City

Antwerpen

State/Province

Vlaanderen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Imelda Ziekenhuis

City

Bonheiden

State/Province

Vlaanderen

ZIP/Postal Code

2820

Country

Belgium

Facility Name

UZ Gent

City

Gent

State/Province

Vlaanderen

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Jessa Ziekenhuis

City

Hasselt

State/Province

Vlaanderen

ZIP/Postal Code

3500

Country

Belgium

Facility Name

UZ Gasthuisberg

City

Leuven

State/Province

Vlaanderen

ZIP/Postal Code

3000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

BACE Trial Substudy 1 - PROactive Substudy

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