The effect of a Bacterial Extract on Asthma Control (BEAC)

ISRCTN ISRCTN14703590
DOI https://doi.org/10.1186/ISRCTN14703590
Secondary identifying numbers 007
Submission date
12/03/2011
Registration date
15/04/2011
Last edited
18/04/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Antonios Christopoulos
Scientific

157 Mezonos Street
Patras
262 21
Greece

Study information

Study designRandomized double blind parallel group prospective study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effect of the oral bacterial extract OM-85 BV on asthma control – a real life study
Study acronymBEAC
Study objectivesEvaluating the additive effect of oral OM-85 BV, Bronho-Vaxom OM Pharma, Geneva, Switzerland), to the combination of inhaled glucocorticosteroids (ICS) plus long-acting beta 2-agonist (LABA), upon the level of asthma control in young adolescents and adult patients.
Our hypothesis was that OM-85 BV would provide additional benefit, as measured by the proportion of patients who would achieve control of their asthma in the lowest step and dose of treatment necessary.
Ethics approval(s)1. University of Patras Reference number 443 from 15.05/004.
2. University of Patras, School of Health Sciences, Greece - Program of Postgraduated Studies in Clinical & Clinical-Laboratory Specialties which function under the Ministerial decision B7/458 π.ε/8.2.02, ΦΕΚ 191/20.2.02, as part of the MSc Thesis 443/17.5.04
Health condition(s) or problem(s) studiedAtopy associated mild to moderate bronchial asthma
Intervention1. Eligible patients received non-blinded the appropriate maintenance treatment (inhaled budesonide 200-800 μg/day plus formoterol 18mcg/day, administered twice daily).
2. The selection of the budesonide dosage was determined by the patients’ level of asthma control and the treatment already commenced
3. Patients were inhaled budesonide and formoterol from a Turbohaler (Pulmicort 200μg and Oxez 9μg respectively, AstraZeneca Liquid Production, Sweden)
4. During the last 2 weeks of this period, single blind placebo OM-85 BV (saccharin) was added
5. In the end of the run-in period patients were reassessed to establish their adherence to the current regimen and level of asthma control. Following, eligible patients were randomized in three strata: Stratum I (uncontrolled, NCA), stratum 2 (partly controlled asthma, PCA) and stratum 3 (controlled asthma, CA).
6. In NCA patients the dose of budesonide was stepped up to 4 times the dose used (up to 1600 μg/day)
7. In PCA patients the dose of budesonide was increased by 50%, while in CA patients budesonide dosage was stepped down by 50%.
8. Following patients in each stratum were randomized according to a central computer generated schedule, to receive either 7mg of OM-85 BV (Bronho-Vaxom; OM PHARMA;Geneva;Switzerland)) or matching placebo saccharin once daily, orally, fasting in the morning
9. Treatment assignments (1:1) were stratified in every stratum according 3 budesonide dose levels (200-400, 400-800 and 800-1600 mcg/day)
10. In the absence of exacerbations and/or adverse events, patients were reassessed every 12 weeks and the dose of budesonide was titrated each time, as prescribed above.
11. During the study, use of theophylline, leukotriene modifiers and extra formoterol was not permitted
12. Nedocromyl nasal spray and eye drops were permitted, in order to treat allergic rhinitis and conjunctivitis respectively
13. The study consistent of two treatment periods: a 4 week run-in and a 24 week double blind
14. Lung Function Tests (spirometry), Skin Prick Tests for aero-allergens and 2 blood samples (1+1 ml) for serum interferon- γ (INF-γ) measurements
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)OM-85 BV - a bacterial extract
Primary outcome measureThe percentage of patients with:
1. Non Controlled Asthma
2. Partly Controlled Asthma
3. Controlled Asthma in every stratum, in the two treatment groups, at the end of the active treatment period
Secondary outcome measures1. Percentage change from baseline in budesonide dosage
2. Mean FEV1 before using a beta 2 agonist
3. Mean PEF, diurnal variability of peak expiratory flow (PEF)
4. Daytime asthma symptoms score
5. Number of night awakenings
6. Total daily as-needed β2 agonist use and serum interferon- γ (INF- γ) levels
Overall study start date01/10/2010
Completion date30/04/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsAbove 100 patients
Key inclusion criteria1. Patients were aged 15-57 years and had a history of persistent asthma for a year or longer, associated with allergy
2. All patients were in regular treatment with combinations of ICS plus LABA, for at least 8 weeks before entering the study
3. Enrolled patients had a Forced Expiratory Volume in one second (FEV1) 60% to 80% of predicted normal, at least 12% reversible to inhaled salbutamol and 15% to 30% diurnal change of Peak Expiratory Flow (PEF)
Key exclusion criteria1. Smoking history of ≥ 10 pack per year and systemic use of corticosteroids
2. Patients with a respiratory tract infection affecting asthma and those who received oral or parental corticosteroids during the 4 week run-in period, chromones, leukotriene receptor antagonists or inhaled anticholinergics during the last 2 weeks, and theophylline or antihistamines during the last week of the run in period were not eligible for randomization 3. As variations in the exposure to domestic mite allergens have a significant impact on asthma related symptoms, patients with history and/or positive skin prick tests for indoor allergens were not included to the study
Date of first enrolment01/10/2010
Date of final enrolment30/04/2011

Locations

Countries of recruitment

  • Greece

Study participating centre

157 Mezonos Street
Patras
262 21
Greece

Sponsor information

University of Patras (Greece)
University/education

Faculty of Medicine
University of Patras
Patras
265 00
Greece

Website http://www.med.upatras.gr
ROR logo "ROR" https://ror.org/017wvtq80

Funders

Funder type

University/education

University of Patras (Greece)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan