SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: 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 asthma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: 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