Overview
SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
Status:
Completed
Completed
Trial end date:
2006-05-01
2006-05-01
Target enrollment:
0
0
Participant gender:
All
All
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 asthmaPhase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AstraZenecaTreatments:
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Formoterol Fumarate
Criteria
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.
- Use of:
1. inhaled glucocorticosteroid treatment for the last 8 weeks prior to inclusion or
ever used oral glucocorticoid treatment for asthma.
2. inhaled long-acting or oral b2-agonists, anticholinergic bronchodilators,
cromones, antihistamines, theophyllines and anti-leukotrienes within 2 weeks of
screening.
3. regular NSAIDs