SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00288379|
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : January 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: formoterol Drug: budesonide/formoterol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|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 Start Date :||October 2004|
|Study Completion Date :||May 2006|
- PD20 methacholine (measured as the change using the measurement before and after each treatment period).
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288379
|Study Director:||AstraZeneca Symbicort Medical Science Director, MD||AstraZeneca|