New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day
Overview[ - collapse ][ - ]
Purpose | This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose. |
---|---|
Condition | Asthma |
Intervention | Drug: Symbicort Drug: Symbicort Drug: Budesonide |
Phase | Phase 3 |
Sponsor | AstraZeneca |
Responsible Party | AstraZeneca |
ClinicalTrials.gov Identifier | NCT01360021 |
First Received | May 19, 2011 |
Last Updated | January 27, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | May 19, 2011 |
---|---|
Last Updated Date | January 27, 2014 |
Start Date | November 2011 |
Estimated Primary Completion Date | August 2012 |
Current Primary Outcome Measures |
|
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day |
---|---|
Official Title | A 12-week, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy Safety, and Patient Use (User Study) of Symbicort® (Budesonide/Formoterol) Breath Actuated Metered Dose Inhaler (BA MDI) 2x160/4.5 μg Twice Daily Compared With Symbicort (Budesonide/Formoterol) AC (Actuation Counter) pMDI® 2x160/4.5 μg Twice Daily and Budesonide AC pMDI 2x160 μg Twice Daily in Adult and Adolescent Asthmatics |
Brief Summary | This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
Condition | Asthma |
Intervention | Drug: Symbicort Breath actuated metered dose inhaler Drug: Symbicort Actuation counter pressured metered dose inhaler Drug: Budesonide Actuation counter pressured metered dose inhaler |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 214 |
Estimated Completion Date | August 2012 |
Estimated Primary Completion Date | August 2012 |
Eligibility Criteria | Inclusion Criteria: - Male or female 12 years and above - Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months - Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal - Patients with reversible airway obstruction - Documented daily use of inhaled corticosteroids for ≥ 3 months Exclusion Criteria: - History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2 - Hospitalized during previous 6 months for asthma - Required emergency treatment more than once during previous 6 months for an asthma-related condition - Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment - Respiratory infection affecting the asthma within 30 days |
Gender | Both |
Ages | 12 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Bulgaria, Hungary, Russian Federation |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01360021 |
---|---|
Other Study ID Numbers | D589OC00003 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | AstraZeneca |
Study Sponsor | AstraZeneca |
Collaborators | Not Provided |
Investigators | Study Director: Goran Eckerwall, MD AstraZeneca R&D, Mölndal |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
Research Site | Huntington Beach, California, United States |
---|---|
Research Site | Long Beach, California, United States |
Research Site | Los Angeles, California, United States |
Research Site | Orange, California, United States |
Research Site | Rancho Mirage, California, United States |
Research Site | Riverside, California, United States |
Research Site | Sacramento, California, United States |
Research Site | San Diego, California, United States |
Research Site | San Jose, California, United States |
Research Site | Tallahassee, Florida, United States |
Research Site | Savannah, Georgia, United States |
Research Site | River Forest, Illinois, United States |
Research Site | Louisville, Kentucky, United States |
Research Site | Metairie, Louisiana, United States |
Research Site | Bangor, Maine, United States |
Research Site | Wheaton, Maryland, United States |
Research Site | North Dartmouth, Massachusetts, United States |
Research Site | Columbia, Missouri, United States |
Research Site | Rolla, Missouri, United States |
Research Site | Skillman, New Jersey, United States |
Research Site | North Syracuse, New York, United States |
Research Site | Rochester, New York, United States |
Research Site | Cincinnati, Ohio, United States |
Research Site | Collegeville, Pennsylvania, United States |
Research Site | Lincoln, Rhode Island, United States |
Research Site | Charleston, South Carolina, United States |
Research Site | Spartanburg, South Carolina, United States |
Research Site | Dallas, Texas, United States |
Research Site | Tacoma, Washington, United States |
Research Site | Greenfield, Wisconsin, United States |
Research Site | Madison, Wisconsin, United States |
Research Site | Ruse, Bulgaria |
Research Site | Sevlievo, Bulgaria |
Research Site | Sofia, Bulgaria |
Research Site | Varna, Bulgaria |
Research Site | Balassagyarmat, Hungary |
Research Site | Budapest, Hungary |
Research Site | Salgotarjan, Hungary |
Research Site | Szazhalombatta, Hungary |
Research Site | Ekaterinburg, Russia, Russian Federation |
Research Site | Moscow, Russia, Russian Federation |