New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day
NCT ID: NCT01360021
Last Updated: 2014-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
214 participants
INTERVENTIONAL
2011-11-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1 Symbicort/inhaler
Symbicort BA MDI 2x160/4.5 μg twice daily
Symbicort
Breath actuated metered dose inhaler
Symbicort/inhaler
Symbicort AC pDMI 2x160/4.5 μg twice daily
Symbicort
Actuation counter pressured metered dose inhaler
Budesonide/inhaler
Budesonide AC pMDI 2x160 μg twice daily
Budesonide
Actuation counter pressured metered dose inhaler
Interventions
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Symbicort
Breath actuated metered dose inhaler
Symbicort
Actuation counter pressured metered dose inhaler
Budesonide
Actuation counter pressured metered dose inhaler
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Goran Eckerwall, MD
Role: STUDY_DIRECTOR
AstraZeneca R&D, Mölndal
Locations
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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
Rousse, Bulgaria, Bulgaria
Research Site
Sevlievo, Bulgaria, Bulgaria
Research Site
Sofia, Bulgaria, Bulgaria
Research Site
Varna, Bulgaria, Bulgaria
Research Site
Balassagyarmat, Hungary, Hungary
Research Site
Budapest, Hungary, Hungary
Research Site
Salgótarján, Hungary, Hungary
Research Site
Százhalombatta, Hungary, Hungary
Research Site
Moscow, Russia, Russia
Research Site
Yekaterinburg, Russia, Russia
Countries
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References
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Murphy KR, Dhand R, Trudo F, Uryniak T, Aggarwal A, Eckerwall G. Therapeutic equivalence of budesonide/formoterol delivered via breath-actuated inhaler vs pMDI. Respir Med. 2015 Feb;109(2):170-9. doi: 10.1016/j.rmed.2014.12.009. Epub 2015 Jan 3.
Other Identifiers
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D589OC00003
Identifier Type: -
Identifier Source: org_study_id
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