BACE Trial Substudy 2 - FarmEc Substudy

Chronic Obstructive Pulmonary Disease Clinical Trial

— FarmEc  

Official title:

BACE Trial - The Pharmaco-economic Impact of the Azithromycin Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205255
• Other study ID #: s55829 - FarmEc Substudy
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2014
• Est. completion date: April 2020

Study information

• Verified date: April 2020
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: April 2020
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Azithromycin
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
• Placebo

Locations

Country	Name	City	State
Belgium	Onze-Lieve-Vrouwziekenhuis	Aalst
Belgium	St. Augustinus Ziekenhuis	Antwerpen	Vlaanderen
Belgium	ZNA Middelheim	Antwerpen	Vlaanderen
Belgium	Imelda Ziekenhuis	Bonheiden	Vlaanderen
Belgium	St. Jan Brugge Ziekenhuis	Brugge	Vlaanderen
Belgium	St. Pieterziekenhuis	Brussel	Brussels Hoofdstedelijk Gewest
Belgium	UZ Brussel	Brussel	Brussel Hoofdstedelijk Gewest
Belgium	CHU Charleroi	Charleroi	Wallonië
Belgium	Maria Middelaresziekenhuis	Gent	Vlaanderen
Belgium	UZ Gent	Gent	Vlaanderen
Belgium	Grand Hôpital de Charleroi	Gilly	Wallonië
Belgium	Jessa Ziekenhuis	Hasselt	Vlaanderen
Belgium	AZ Groeninge Ziekenhuis	Kortrijk	Vlaanderen
Belgium	UZ Gasthuisberg	Leuven	Vlaanderen
Belgium	CHU Liège	Liège	Wallonië
Belgium	Clinique Reine Astrid	Malmedy
Belgium	Clinique Sainte-Elisabeth	Namur
Belgium	Heilig Hart Ziekenhuis	Roeselare	Vlaanderen
Belgium	St. Andriesziekenhuis	Tielt	Vlaanderen
Belgium	CHU Mont-Godinne	Yvoir	Wallonië

Sponsors (1)

Lead Sponsor	Collaborator
Wim Janssens

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 9 month interval