![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00419757 |
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the Hispanic population.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Budesonide/formoterol (SYMBICORT) pMDI Drug: Budesonide HFA pMDI |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week, Randomised, Double Blind, Active-Controlled, Multi-Centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma |
Estimated Enrollment: | 240 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | June 2008 |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Christer Hultquist, MD | AstraZeneca |
Study ID Numbers: | D5896C00021 |
Study First Received: | January 5, 2007 |
Last Updated: | March 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00419757 |
Health Authority: | United States: Food and Drug Administration |
Moderate asthma Severe asthma |
Hypersensitivity Lung Diseases, Obstructive Symbicort Respiratory Tract Diseases Lung Diseases |
Budesonide Hypersensitivity, Immediate Formoterol Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents |
Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |