SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: formoterol (Drug); budesonide/formoterol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
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
Clinical Details
Official title: A Comparative, Placebo-Controlled, Double Blind, Double Dummy, Cross-Over, Single Centre, Phase IIIb Study Between Formoterol Alone (Oxis® Turbuhaler® 4.5 µg) and the Fixed Combination of Formoterol and Budesonide (Symbicort® Turbuhaler®160/4.5 µg) on Airway Responsiveness and Airway Inflammation Induced by Repeated Low-Dose Allergen Challenge in Allergic Patients With Mild Asthma
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: PD20 methacholine (measured as the change using the measurement before and after each treatment period).
Secondary outcome: 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).
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
Research Site, Stockholm, Sweden
Additional Information
Starting date: November 2004
Last updated: May 29, 2006
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