New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day (BAI)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01360021
First received: May 19, 2011
Last updated: January 3, 2013
Last verified: January 2013
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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 | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Symbicort Drug: Budesonide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Forced expiratory volume in 1 second (FEV1) [ Time Frame: Pre AM dose in clinic visits at baseline, and week 3, 7 and 12 ] [ Designated as safety issue: No ]
- Forced expiratory volume in 1 second (FEV1) [ Time Frame: 60 minutes post-dose in clinic visits at baseline, and week 3, 7 and 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Peek expiratory flow [ Time Frame: Recorded morning upon rising and evening before sleep for 14 weeks ] [ Designated as safety issue: No ]
- Asthma symptoms and use of rescue medications [ Time Frame: Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks ] [ Designated as safety issue: No ]
- Night-time awakenings due to asthma symptoms [ Time Frame: Recorded 6:00 - 11:00 AM for 14 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 214 |
| Study Start Date: | November 2011 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1 Symbicort/inhaler
Symbicort BA MDI 2x160/4.5 μg twice daily
|
Drug: Symbicort
Breath actuated metered dose inhaler
|
|
Active Comparator: Symbicort/inhaler
Symbicort AC pDMI 2x160/4.5 μg twice daily
|
Drug: Symbicort
Actuation counter pressured metered dose inhaler
|
|
Active Comparator: Budesonide/inhaler
Budesonide AC pMDI 2x160 μg twice daily
|
Drug: Budesonide
Actuation counter pressured metered dose inhaler
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360021
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| United States, California | |
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| Huntington Beach, California, United States | |
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| Long Beach, California, United States | |
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| Los Angeles, California, United States | |
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| Orange, California, United States | |
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| Rancho Mirage, California, United States | |
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| Riverside, California, United States | |
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| Sacramento, California, United States | |
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| San Diego, California, United States | |
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| San Jose, California, United States | |
| United States, Florida | |
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| Tallahassee, Florida, United States | |
| United States, Georgia | |
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| Savannah, Georgia, United States | |
| United States, Illinois | |
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| River Forest, Illinois, United States | |
| United States, Kentucky | |
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| Louisville, Kentucky, United States | |
| United States, Louisiana | |
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| Metairie, Louisiana, United States | |
| United States, Maine | |
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| Bangor, Maine, United States | |
| United States, Maryland | |
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| Wheaton, Maryland, United States | |
| United States, Massachusetts | |
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| North Dartmouth, Massachusetts, United States | |
| United States, Missouri | |
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| Columbia, Missouri, United States | |
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| Rolla, Missouri, United States | |
| United States, New Jersey | |
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| Skillman, New Jersey, United States | |
| United States, New York | |
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| North Syracuse, New York, United States | |
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| Rochester, New York, United States | |
| United States, Ohio | |
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| Cincinnati, Ohio, United States | |
| United States, Pennsylvania | |
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| Collegeville, Pennsylvania, United States | |
| United States, Rhode Island | |
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| Lincoln, Rhode Island, United States | |
| United States, South Carolina | |
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| Charleston, South Carolina, United States | |
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| Spartanburg, South Carolina, United States | |
| United States, Texas | |
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| Dallas, Texas, United States | |
| United States, Washington | |
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| Tacoma, Washington, United States | |
| United States, Wisconsin | |
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| Greenfield, Wisconsin, United States | |
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| Madison, Wisconsin, United States | |
| Bulgaria | |
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| Ruse, Bulgaria | |
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| Sevlievo, Bulgaria | |
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| Sofia, Bulgaria | |
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| Varna, Bulgaria | |
| Hungary | |
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| Balassagyarmat, Hungary | |
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| Budapest, Hungary | |
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| Salgotarjan, Hungary | |
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| Szazhalombatta, Hungary | |
| Russian Federation | |
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| Ekaterinburg, Russia, Russian Federation | |
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| Moscow, Russia, Russian Federation | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Goran Eckerwall, MD | AstraZeneca R&D, Mölndal |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01360021 History of Changes |
| Other Study ID Numbers: | D589OC00003 |
| Study First Received: | May 19, 2011 |
| Last Updated: | January 3, 2013 |
| Health Authority: | United States: Food and Drug Administration Bulgaria: Executive Drug Agency Hungary: National Institute of Pharmacy Russia: Ministry of Health of the Russian Federation |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Symbicort Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 21, 2013