BACE Trial Substudy 2 - FarmEc Substudy

NCT02205255 | Completed Phase 3

• 1 other identifier: s55829 - FarmEc Substudy
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 20

Brief Summary

A second sub-analysis of the BACE trial will include a detailed cost-effectiveness study.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

AECOPD; Chronic Obstructive Pulmonary Disease; Acute exacerbation; Hospitalization; Azithromycin; Macrolides; Randomized Controlled Trial; Placebo; Economic Impact; Cost-effectiveness; EQ5D

Outcome Measures

Primary Outcomes (1)

• 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

  At 3 month interval

Secondary Outcomes (1)

• Total cost (direct and Indirect cost) during the entire study participation

  At 9 month interval

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

Drug: Azithromycin

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

Drug: Placebo

Interventions

Azithromycin DRUG

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

Placebo DRUG

Also known as: Inactive substance

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Wim Janssens: lead

Study Sites (20)

UZ Brussel

Brussels, Brussel Hoofdstedelijk Gewest, 1090, Belgium

Location

St. Pieterziekenhuis

Brussels, Brussels Capital, 1000, Belgium

Location

ZNA Middelheim

Antwerp, Flanders, 2020, Belgium

Location

St. Augustinus Ziekenhuis

Antwerp, Flanders, 2610, Belgium

Location

Imelda Ziekenhuis

Bonheiden, Flanders, 2820, Belgium

Location

St. Jan Brugge Ziekenhuis

Bruges, Flanders, 8000, Belgium

Location

Maria Middelaresziekenhuis

Ghent, Flanders, 9000, Belgium

Location

UZ Gent

Ghent, Flanders, 9000, Belgium

Location

Jessa Ziekenhuis

Hasselt, Flanders, 3500, Belgium

Location

AZ Groeninge Ziekenhuis

Kortrijk, Flanders, 8500, Belgium

Location

UZ Gasthuisberg

Leuven, Flanders, 3000, Belgium

Location

Heilig Hart Ziekenhuis

Roeselare, Flanders, 8800, Belgium

Location

St. Andriesziekenhuis

Tielt, Flanders, 8700, Belgium

Location

CHU Charleroi

Charleroi, Wallonia, 6110, Belgium

Location

Grand Hôpital de Charleroi

Gilly, Wallonia, 6060, Belgium

Location

CHU Liège

Liège, Wallonia, 4000, Belgium

Location

CHU Mont-Godinne

Yvoir, Wallonia, 5530, Belgium

Location

Onze-Lieve-Vrouwziekenhuis

Aalst, 9300, Belgium

Location

Clinique Reine Astrid

Malmedy, 4960, Belgium

Location

Clinique Sainte-Elisabeth

Namur, 5000, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

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 23, 2014
• First Posted: July 31, 2014
• Study Start: August 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 (20)