NCT02205242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

3.6 years

First QC Date

July 22, 2014

Last Update Submit

April 7, 2020

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

AECOPDChronic Obstructive Pulmonary DiseaseAcute exacerbationHospitalizationAzithromycinMacrolidesRandomized Controlled TrialPlaceboPhysical ActivityPRO-ActiveActivity Monitor

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

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

    0 and 3 months

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

    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

    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

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

Other Outcomes (1)

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

    at 0, 3 and 9 months

Study Arms (2)

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

Drug: AzithromycinDevice: Dynaport®

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

Device: Dynaport®Drug: Placebo

Interventions

AzithromycinDRUG

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

Also known as: Azitromcyine CF, ATC code: J01FA10
Azithromycin
Dynaport®DEVICE

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

Also known as: Activity monitor
AzithromycinPlacebo
PlaceboDRUG
Also known as: Inactive substance
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

St. Pieterziekenhuis

Brussels, Brussels Capital, 1000, Belgium

Location

ZNA Middelheim

Antwerp, Flanders, 2020, Belgium

Location

Imelda Ziekenhuis

Bonheiden, Flanders, 2820, Belgium

Location

UZ Gent

Ghent, Flanders, 9000, Belgium

Location

Jessa Ziekenhuis

Hasselt, Flanders, 3500, Belgium

Location

UZ Gasthuisberg

Leuven, Flanders, 3000, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor Activity

Interventions

AzithromycinFitness Trackers

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsDiagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Officials

  • Wim Janssens, MD PhD

    KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD. Phd.

Study Record Dates

First Submitted

July 22, 2014

First Posted

July 31, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(6)