Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics
NCT ID: NCT01747629
Last Updated: 2015-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
160 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
* At least 12 years of age at screening
* General good health
* Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility
* Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.
* Ability to perform spirometry in an acceptable manner as per protocol guidelines
Exclusion Criteria
* History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).
* 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 SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
* Hospitalization due to asthma exacerbation 2 or more times in the past year
* Initiation of immunotherapy or dose escalation during the study period
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 10225
Costa Mesa, California, United States
Teva Investigational Site 10250
Encinitas, California, United States
Teva Investigational Site 10230
Huntington Beach, California, United States
Teva Investigational Site 10255
Palmdale, California, United States
Teva Investigational Site 10231
Rancho Mirage, California, United States
Teva Investigational Site 10252
Riverside, California, United States
Teva Investigational Site 10242
Rolling Hills Estates, California, United States
Teva Investigational Site 10238
San Diego, California, United States
Teva Investigational Site 10243
San Jose, California, United States
Teva Investigational Site 10247
Miami Lakes, Florida, United States
Teva Investigational Site 10239
Tallahassee, Florida, United States
Teva Investigational Site 10234
Tampa, Florida, United States
Teva Investigational Site 10253
Bangor, Maine, United States
Teva Investigational Site 10257
Baltimore, Maryland, United States
Teva Investigational Site 10254
White Marsh, Maryland, United States
Teva Investigational Site 10235
Fall River, Massachusetts, United States
Teva Investigational Site 10236
North Dartmouth, Massachusetts, United States
Teva Investigational Site 10226
Minneapolis, Minnesota, United States
Teva Investigational Site 10233
Minneapolis, Minnesota, United States
Teva Investigational Site 10241
St Louis, Missouri, United States
Teva Investigational Site 10229
Bellevue, Nebraska, United States
Teva Investigational Site 10227
Rochester, New York, United States
Teva Investigational Site 10244
Charlotte, North Carolina, United States
Teva Investigational Site 10248
Cincinnati, Ohio, United States
Teva Investigational Site 10249
Oklahoma City, Oklahoma, United States
Teva Investigational Site 10232
Eugene, Oregon, United States
Teva Investigational Site 10259
Medford, Oregon, United States
Teva Investigational Site 10237
Portland, Oregon, United States
Teva Investigational Site 10240
Bethlehem, Pennsylvania, United States
Teva Investigational Site 10246
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 10256
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 10251
Rock Hill, South Carolina, United States
Teva Investigational Site 10228
Spartanburg, South Carolina, United States
Teva Investigational Site 10258
San Antonio, Texas, United States
Teva Investigational Site 10245
Seattle, 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-304
Identifier Type: -
Identifier Source: org_study_id
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