Back to resultsSMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
formoterol
budesonide/formoterol
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, allergen challenge, airway responsiveness, airway inflammation, Symbicort®
Eligibility 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: 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
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
PD20 methacholine (measured as the change using the measurement before and after each treatment period).
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00288379
Brief Title
SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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, induced by repeated low-dose allergen challenge in allergic patients with mild asthma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, allergen challenge, airway responsiveness, airway inflammation, Symbicort®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
formoterol
Intervention Type
Drug
Intervention Name(s)
budesonide/formoterol
Primary Outcome Measure Information:
Title
PD20 methacholine (measured as the change using the measurement before and after each treatment period).
Secondary Outcome Measure Information:
Title
eNO (ppb).
Title
Forced Expiratory Volume in one second (FEV1 ) - Induced sputum:
Title
Total and differential blood cell count
Title
Different Biomarkers
Title
Safety endpoints will be incidence of Serious Adverse Events (SAEs)
Title
Discontinuation due to Adverse Events (DAEs).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Symbicort Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
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