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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: formoterol
* Drug: budesonide/formoterol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: formoterol|nan|
|Drug: budesonide/formoterol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD20 methacholine (measured as the change using the measurement before and after each treatment period). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, allergen challenge, airway responsiveness, airway inflammation, Symbicort®