SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00288379
- Lead Sponsor
- AstraZeneca
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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:
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method PD20 methacholine (measured as the change using the measurement before and after each treatment period).
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Research Site
🇸🇪Stockholm, Sweden