Status:
COMPLETED
Study to Investigate the Efficacy of Symbicort® SMART.
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one i...
Eligibility Criteria
Inclusion
- Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.
- Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
- Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.
Exclusion
- Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.
- Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
2091 Patients enrolled
Trial Details
Trial ID
NCT00839800
Start Date
February 1 2009
End Date
February 1 2011
Last Update
November 30 2012
Active Locations (109)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Buenos Aires, Argentina, Argentina
2
Research Site
Capital Federal, Buenos Aires, Argentina
3
Research Site
Mar del Plata, Buenos Aires, Argentina
4
Research Site
Monte Grande, Buenos Aires, Argentina