Status:
COMPLETED
SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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, ind...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00288379
Start Date
October 1 2004
End Date
May 1 2006
Last Update
January 24 2011
Active Locations (1)
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1
Research Site
Stockholm, Sweden