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Chronic Obstructive Pulmonary DiseasePhase 3FarmEcNCT02205255

BACE Trial Substudy 2 - FarmEc Substudy

A Phase 3 study testing Azithromycin in people with Chronic Obstructive Pulmonary Disease, run by Wim Janssens at 20 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Azithromycin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
20 sitesBelgium
Study dates
1 Aug 2014to Apr 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Belgium20 sites

  • Onze-Lieve-Vrouwziekenhuis

    Aalst, 9300

  • ZNA Middelheim

    Antwerp, Flanders, 2020

  • St. Augustinus Ziekenhuis

    Antwerp, Flanders, 2610

  • Imelda Ziekenhuis

    Bonheiden, Flanders, 2820

  • St. Jan Brugge Ziekenhuis

    Bruges, Flanders, 8000

  • UZ Brussel

    Brussels, Brussel Hoofdstedelijk Gewest, 1090

  • St. Pieterziekenhuis

    Brussels, Brussels Capital, 1000

  • CHU Charleroi

    Charleroi, Wallonia, 6110

  • Maria Middelaresziekenhuis

    Ghent, Flanders, 9000

  • UZ Gent

    Ghent, Flanders, 9000

  • Grand Hôpital de Charleroi

    Gilly, Wallonia, 6060

  • Jessa Ziekenhuis

    Hasselt, Flanders, 3500

  • AZ Groeninge Ziekenhuis

    Kortrijk, Flanders, 8500

  • UZ Gasthuisberg

    Leuven, Flanders, 3000

  • CHU Liège

    Liège, Wallonia, 4000

  • Clinique Reine Astrid

    Malmedy, 4960

  • Clinique Sainte-Elisabeth

    Namur, 5000

  • Heilig Hart Ziekenhuis

    Roeselare, Flanders, 8800

  • St. Andriesziekenhuis

    Tielt, Flanders, 8700

  • CHU Mont-Godinne

    Yvoir, Wallonia, 5530

Other trials in Belgium

About this study

Official title: BACE Trial - The Pharmaco-economic Impact of the Azithromycin Intervention

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

Read the 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).

Being tested
Azithromycin, Placebo
Keywords
AECOPD, Chronic Obstructive Pulmonary Disease, Acute exacerbation, Hospitalization, Azithromycin, Macrolides, Randomized Controlled Trial, Placebo, Economic Impact, Cost-effectiveness, EQ5D
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AzithromycinDrug

    Also called Azitromcyine CF, ATC code: J01FA10

    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

  • PlaceboDrug

    Also called Inactive substance

Study groups in NCT02205255
Study groupRoleWhat they receive
AzithromycinExperimentalN = 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
Receives: Drug: Azithromycin
PlaceboPlacebo comparatorN = 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At 3 month interval

Secondary outcomes (1)

  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

    Measured: At 9 month interval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2014 (estimated)
  2. Study start1 Aug 2014
  3. Primary completionApr 2018
  4. Study completionApr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02205255
Sponsor's protocol ID
s55829 - FarmEc Substudy
Acronym
FarmEc
Status last verified
Apr 2020
First submitted
23 Jul 2014
Last updated
8 Apr 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azithromycin in people with Chronic Obstructive Pulmonary Disease, run by Wim Janssens at 20 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total cost (direct and Indirect cost) during the entire study participation (time frame: At 3 month interval). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02205255.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.

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BACE Trial Substudy 2 - FarmEc Substudy (NCT02205255) | AzTrials