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BACE Trial Substudy 2 - FarmEc Substudy (FarmEc)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Azithromycin
Placebo
Sponsored by
Wim Janssens
About
Eligibility
Locations
Arms
Outcomes
Full info

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, Economic Impact, Cost-effectiveness, EQ5D

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

  • UZ Brussel
  • St. Pieterziekenhuis
  • ZNA Middelheim
  • St. Augustinus Ziekenhuis
  • Imelda Ziekenhuis
  • St. Jan Brugge Ziekenhuis
  • Maria Middelaresziekenhuis
  • UZ Gent
  • Jessa Ziekenhuis
  • AZ Groeninge Ziekenhuis
  • UZ Gasthuisberg
  • Heilig Hart Ziekenhuis
  • St. Andriesziekenhuis
  • CHU Charleroi
  • Grand Hôpital de Charleroi
  • CHU Liège
  • CHU Mont-Godinne
  • Onze-Lieve-Vrouwziekenhuis
  • Clinique Reine Astrid
  • Clinique Sainte-Elisabeth

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 = 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

Outcomes

Primary Outcome Measures

Total cost (direct and Indirect cost) during the entire study participation
Direct costs (including drugs, physician visits, laboratory tests, technical exams, medical imaging, hospital stay) will be assessed by collecting the medical resource use data retrospectively via hospital invoices and prospectively via patient diaries. Indirect costs (relating to time, convenience, and transportation) will be assessed by collecting the medical resource use data prospectively via patient diaries. This outcome measure will also be analysed in following subgroups: 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

Secondary Outcome Measures

Total cost (direct and Indirect cost) during the entire study participation
Direct costs (including drugs, physician visits, laboratory tests, technical exams, medical imaging, hospital stay) will be assessed by collecting the medical resource use data retrospectively via hospital invoices and prospectively via patient diaries. Indirect costs (relating to time, convenience, and transportation) will be assessed by collecting the medical resource use data prospectively via patient diaries. This outcome measure will also be analysed in following subgroups: 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

Full Information

First Posted
July 23, 2014
Last Updated
April 7, 2020
Sponsor
Wim Janssens
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1. Study Identification

Unique Protocol Identification Number
NCT02205255
Brief Title
BACE Trial Substudy 2 - FarmEc Substudy
Acronym
FarmEc
Official Title
BACE Trial - The Pharmaco-economic Impact of the Azithromycin Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A second sub-analysis of the BACE trial will include a detailed cost-effectiveness study.
Detailed Description
Our multicenter randomized trial executed in one country will provide an excellent tool for more precise health economic assessments. In a first approach, rough estimates on savings of direct costs in the entire study cohort will be made by taking into account the Flemish average costs for a single hospitalization day at a respiratory ward, for a day at intensive care, for an emergency visit, for a home physician contact and for an antibiotic-steroid course. A more detailed cost-effectiveness and cost-utility analysis at 3 and 9 months interval will only be performed in case significant clinical benefits are found in favor of the active treatment. For this purpose medical resource use data will be collected retrospectively via hospital invoices (direct costs including drugs, physician visits, laboratory tests, technical exams, medical imaging, hospital stay) but also prospectively via patient diaries, to cover direct and indirect costs during the entire outpatient period, and will be linked to EQ5D scores. Patient will have to give informed consent that additional to the clinical evaluation, invoices will be collected. However, individual patients can still opt out for these analyses (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, Economic Impact, Cost-effectiveness, EQ5D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin
Arm Type
Experimental
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
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
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inactive substance
Primary Outcome Measure Information:
Title
Total cost (direct and Indirect cost) during the entire study participation
Description
Direct costs (including drugs, physician visits, laboratory tests, technical exams, medical imaging, hospital stay) will be assessed by collecting the medical resource use data retrospectively via hospital invoices and prospectively via patient diaries. Indirect costs (relating to time, convenience, and transportation) will be assessed by collecting the medical resource use data prospectively via patient diaries. This outcome measure will also be analysed in following subgroups: 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 3 month interval
Secondary Outcome Measure Information:
Title
Total cost (direct and Indirect cost) during the entire study participation
Description
Direct costs (including drugs, physician visits, laboratory tests, technical exams, medical imaging, hospital stay) will be assessed by collecting the medical resource use data retrospectively via hospital invoices and prospectively via patient diaries. Indirect costs (relating to time, convenience, and transportation) will be assessed by collecting the medical resource use data prospectively via patient diaries. This outcome measure will also be analysed in following subgroups: 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 9 month interval

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
UZ Brussel
City
Brussel
State/Province
Brussel Hoofdstedelijk Gewest
ZIP/Postal Code
1090
Country
Belgium
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
St. Augustinus Ziekenhuis
City
Antwerpen
State/Province
Vlaanderen
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Imelda Ziekenhuis
City
Bonheiden
State/Province
Vlaanderen
ZIP/Postal Code
2820
Country
Belgium
Facility Name
St. Jan Brugge Ziekenhuis
City
Brugge
State/Province
Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Maria Middelaresziekenhuis
City
Gent
State/Province
Vlaanderen
ZIP/Postal Code
9000
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
AZ Groeninge Ziekenhuis
City
Kortrijk
State/Province
Vlaanderen
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
State/Province
Vlaanderen
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Heilig Hart Ziekenhuis
City
Roeselare
State/Province
Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Facility Name
St. Andriesziekenhuis
City
Tielt
State/Province
Vlaanderen
ZIP/Postal Code
8700
Country
Belgium
Facility Name
CHU Charleroi
City
Charleroi
State/Province
Wallonië
ZIP/Postal Code
6110
Country
Belgium
Facility Name
Grand Hôpital de Charleroi
City
Gilly
State/Province
Wallonië
ZIP/Postal Code
6060
Country
Belgium
Facility Name
CHU Liège
City
Liège
State/Province
Wallonië
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Mont-Godinne
City
Yvoir
State/Province
Wallonië
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Onze-Lieve-Vrouwziekenhuis
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Clinique Reine Astrid
City
Malmedy
ZIP/Postal Code
4960
Country
Belgium
Facility Name
Clinique Sainte-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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BACE Trial Substudy 2 - FarmEc Substudy

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