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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: budesonide/formoterol

Drug: formoterol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00288379

D5890L00007

EudraCT No 2004-000211-26

Details and patient eligibility

About

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

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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