NCT00288379CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- PD20 methacholine (measured as the change using the measurement before and after each treatment period).
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A diagnosed history of asthma for at least 6 months
- •Mild and stable asthma, only using β2-agonists as needed for the last 4 weeks.
- •FEV1 >70% of predicted normal value (post-bronchodilator value).
- •Skin prick test positive to pollen, animal dander or house dust mite.
Exclusion Criteria
- •Any significant respiratory disease, other than asthma.
- •Upper or lower respiratory tract infection within 4 weeks before inclusion.
- •inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or ever used oral glucocorticoid treatment for asthma.
- •inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators, cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of screening.
- •regular NSAIDs
Outcomes
Primary Outcomes
PD20 methacholine (measured as the change using the measurement before and after each treatment period).
Secondary Outcomes
- 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).
Investigators
Study Sites (1)
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