SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
To compare the effects of formoterol alone (Oxis® TurbuhalerÒ) and the fixed combination of formoterol and budesonide (Symbicort® TurbuhalerÒ) on airway responsiveness as a marker of inflammation, induced by repeated low-dose allergen challenge in allergic patients with mild asthma
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Comparative, Placebo-controlled, Double Blind, Double Dummy, Cross-over, Single Centre, Phase IIIb Study Between Formoterol Alone (Oxis® Turbuhaler® 4.5 µg) and the Fixed Combination of Formoterol and Budesonide (Symbicort® Turbuhaler®160/4.5 µg) on Airway Responsiveness and Airway Inflammation Induced by Repeated Low-dose Allergen Challenge in Allergic Patients With Mild Asthma|
- PD20 methacholine (measured as the change using the measurement before and after each treatment period).
- eNO (ppb).
- Forced Expiratory Volume in one second (FEV1 ) - Induced sputum:
- Total and differential blood cell count
- Different Biomarkers
- Safety endpoints will be incidence of Serious Adverse Events (SAEs)
- Discontinuation due to Adverse Events (DAEs).
|Study Start Date:||October 2004|
|Study Completion Date:||May 2006|