A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma
NCT ID: NCT01424813
Last Updated: 2015-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
158 participants
INTERVENTIONAL
2012-12-31
2013-11-30
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
QUADRUPLE
Study Groups
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Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Placebo MDPI
Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Albuterol MDPI
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Albuterol MDPI
Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Interventions
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Placebo MDPI
Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Albuterol MDPI
Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* General good health
* Persistent asthma, with an FEV1 50-80% predicted.
* Ability to perform spirometry in an acceptable manner as per protocol guidelines.
* Ability to perform PEFR with a handheld peak flow meter.
* Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.
* Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.
* Non-smokers.
* Capable of understanding the requirements, risks, and benefits of study participation.
Exclusion Criteria
* A known hypersensitivity to albuterol or any of the excipients in the formulations.
* History of severe milk protein allergy.
* History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).
* Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.
* History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
* Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).
* Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
12 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Project Leader
Role: STUDY_DIRECTOR
Teva Respiratory R&D
Locations
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Teva Investigational Site 10077
Birmingham, Alabama, United States
Teva Investigational Site 10079
Phoenix, Arizona, United States
Teva Investigational Site 10569
Costa Mesa, California, United States
Teva Investigational Site 10053
Fountain Valley, California, United States
Teva Investigational Site 10065
Huntington Beach, California, United States
Teva Investigational Site 10572
Huntington Beach, California, United States
Teva Investigational Site 10075
Los Angeles, California, United States
Teva Investigational Site 10061
Roseville, California, United States
Teva Investigational Site 10066
San Diego, California, United States
Teva Investigational Site 10068
Denver, Colorado, United States
Teva Investigational Site 10069
Denver, Colorado, United States
Teva Investigational Site 10058
Miami, Florida, United States
Teva Investigational Site 10060
Miami, Florida, United States
Teva Investigational Site 10064
Ormond Beach, Florida, United States
Teva Investigational Site 10071
Savannah, Georgia, United States
Teva Investigational Site 10073
Wichita, Kansas, United States
Teva Investigational Site 10070
Owensboro, Kentucky, United States
Teva Investigational Site 10063
Bethesda, Maryland, United States
Teva Investigational Site 10571
Gaithersburg, Maryland, United States
Teva Investigational Site 10067
Wheaton, Maryland, United States
Teva Investigational Site 10072
St Louis, Missouri, United States
Teva Investigational Site 10050
Missoula, Montana, United States
Teva Investigational Site 10057
Raleigh, North Carolina, United States
Teva Investigational Site 10051
Cincinnati, Ohio, United States
Teva Investigational Site 10078
Sylvania, Ohio, United States
Teva Investigational Site 10054
Oklahoma City, Oklahoma, United States
Teva Investigational Site 10568
Oklahoma City, Oklahoma, United States
Teva Investigational Site 10055
Tulsa, Oklahoma, United States
Teva Investigational Site 10056
Medford, Oregon, United States
Teva Investigational Site 10076
Medford, Oregon, United States
Teva Investigational Site 10684
Charleston, South Carolina, United States
Teva Investigational Site 10570
Spartanburg, South Carolina, United States
Teva Investigational Site 10049
Live Oak, Texas, United States
Teva Investigational Site 10052
San Antonio, Texas, United States
Teva Investigational Site 10685
Waco, Texas, United States
Teva Investigational Site 10059
Fairfax, Virginia, United States
Teva Investigational Site 10074
Puyallup, Washington, United States
Teva Investigational Site 10062
Tacoma, Washington, United States
Countries
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References
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Raphael G, Taveras H, Iverson H, O'Brien C, Miller D. Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma. J Asthma. 2016;53(2):187-93. doi: 10.3109/02770903.2015.1070862. Epub 2015 Sep 15.
Other Identifiers
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ABS-AS-301
Identifier Type: -
Identifier Source: org_study_id
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