Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®
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|ClinicalTrials.gov Identifier: NCT01803555|
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : August 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Budesonide/Formoterol SPIROMAX® Drug: SYMBICORT® TURBOHALER®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||605 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 12-Week Efficacy and Safety Evaluation of Budesonidel/Formoterol SPIROMAX® 160/4.5 mcg Inhalation Powder Versus SYMBICORT® TURBOHALER® 200/6 mcg in Adult and Adolescent Patients With Persistent Asthma|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Budesonide/Formoterol SPIROMAX®
2 inhalations of BF Spiromax at a dosage of 160/4.5 mcg and 2 inhalations of SYMBICORT placebo administered twice daily (AM and PM) during the 12-week treatment period.
Drug: Budesonide/Formoterol SPIROMAX®
Active Comparator: SYMBICORT® TURBOHALER®
2 inhalations of SYMBICORT TURBOHALER at a dosage of 200/6 mcg and 2 inhalations of placebo SPIROMAX administered twice daily (AM and PM) during the 12-week treatment period.
Drug: SYMBICORT® TURBOHALER®
- Change from baseline in weekly average of daily trough (predose and pre-rescue bronchodilator) AM Peak expiratory flow (PEF) [ Time Frame: 12 weeks ]
- Change from baseline in weekly average of daily PM PEF [ Time Frame: 12 weeks ]
- Safety Parameters [ Time Frame: From signing of the informed consent form through the 12 week treatment period ]The safety of BF SPIROMAX will be assessed throughout the study by evaluating adverse events, oropharynx examination results, physical examination results, and vital signs measurements.
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): NCT01803555
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