Atopy associated mild to moderate bronchial asthma Respiratory Asthma
Conditions
Interventions
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 budeso
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-
Sponsors
University of Patras (Greece)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 ß2 agonist use and serum interferon- ? (INF- ?) levels | — |
Countries
Greece
Outcome results
None listed