Clinical trial NCT02205255: BACE Trial Substudy 2 - FarmEc Substudy
Official title: BACE Trial - The Pharmaco-economic Impact of the Azithromycin Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Total cost (direct and Indirect cost) during the entire study participation
timeFrame: At 3 month interval
Secondary outcomes:
measure: Total cost (direct and Indirect cost) during the entire study participation
timeFrame: At 9 month interval
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
state: Brussel Hoofdstedelijk Gewest
city: Brussel
country: Belgium
facility: St. Pieterziekenhuis
state: Brussels Hoofdstedelijk Gewest
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
state: Vlaanderen
city: Antwerpen
country: Belgium
facility: St. Augustinus Ziekenhuis
state: Vlaanderen
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
state: Vlaanderen
city: Brugge
country: Belgium
facility: St. Jan Brugge Ziekenhuis
state: Vlaanderen
city: Gent
country: Belgium
facility: Maria Middelaresziekenhuis
state: Vlaanderen
city: Gent
country: Belgium
facility: UZ Gent
state: Vlaanderen
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
state: Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge Ziekenhuis
state: Vlaanderen
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
state: Vlaanderen
city: Roeselare
country: Belgium
facility: Heilig Hart Ziekenhuis
state: Vlaanderen
city: Tielt
country: Belgium
facility: St. Andriesziekenhuis
state: Vlaanderen
city: Charleroi
country: Belgium
facility: CHU Charleroi
state: Wallonië
city: Gilly
country: Belgium
facility: Grand Hôpital de Charleroi
state: Wallonië
city: Liège
country: Belgium
facility: CHU Liège
state: Wallonië
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
state: Wallonië
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis
city: Malmedy
country: Belgium
facility: Clinique Reine Astrid
city: Namur
country: Belgium
facility: Clinique Sainte-Elisabeth
Study officials:
affiliation: KU Leuven
name: Wim Janssens, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: