Condition category
Respiratory
Date applied
12/03/2011
Date assigned
15/04/2011
Last edited
18/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Antonios Christopoulos

ORCID ID

Contact details

157 Mezonos Street
Patras
262 21
Greece

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

007

Study information

Scientific title

The effect of the oral bacterial extract OM-85 BV on asthma control – a real life study

Acronym

BEAC

Study hypothesis

Evaluating 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

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

Study design

Randomized double blind parallel group prospective study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Atopy associated mild to moderate bronchial asthma

Intervention

1. 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 type

Drug

Phase

Not Applicable

Drug names

OM-85 BV - a bacterial extract

Primary outcome measures

The 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 measures

1. 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 trial start date

01/10/2010

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Above 100 patients

Participant exclusion criteria

1. 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

Recruitment start date

01/10/2010

Recruitment end date

30/04/2011

Locations

Countries of recruitment

Greece

Trial participating centre

157 Mezonos Street
Patras
262 21
Greece

Sponsor information

Organisation

University of Patras (Greece)

Sponsor details

Faculty of Medicine
University of Patras
Patras
265 00
Greece

Sponsor type

University/education

Website

http://www.med.upatras.gr

Funders

Funder type

University/education

Funder name

University of Patras (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes