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

Completed

Conditions: Atopy associated mild to moderate bronchial asthma
Respiratory
Asthma

Registration Number: ISRCTN14703590

Lead Sponsor: niversity of Patras (Greece)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

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)

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of patients with:<br>1. Non Controlled Asthma<br>2. Partly Controlled Asthma <br>3. Controlled Asthma in every stratum, in the two treatment groups, at the end of the active treatment period

Secondary Outcome Measures

Name	Time	Method
1. Percentage change from baseline in budesonide dosage<br>2. Mean FEV1 before using a beta 2 agonist<br>3. Mean PEF, diurnal variability of peak expiratory flow (PEF)<br>4. Daytime asthma symptoms score<br>5. Number of night awakenings<br>6. Total daily as-needed ß2 agonist use and serum interferon- ? (INF- ?) levels