A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing
NCT ID: NCT01218009
Last Updated: 2015-05-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
331 participants
INTERVENTIONAL
2010-10-31
2010-12-31
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
QUADRUPLE
Study Groups
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Albuterol Spiromax
Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Albuterol Spiromax
Albuterol as a dry-powder inhaled orally using the Spiromax inhaler. Each inhalation delivers 90 micrograms (mcg). During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total dose of 720 micrograms per day for those paricipants randomized to the Albuterol treatment arm.
The double-blind period is followed by a 40-week open-label period in which all study participants will take Albuterol Spiromax 90 micrograms (mcg)/inhalation as needed (PRN).
Placebo Spiromax
Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Placebo Spiromax
Placebo as a dry-powder inhaled orally using the Spiromax inhaler. During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
Albuterol Spiromax
Albuterol as a dry-powder inhaled orally using the Spiromax inhaler. Each inhalation delivers 90 micrograms (mcg). During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total dose of 720 micrograms per day for those paricipants randomized to the Albuterol treatment arm.
The double-blind period is followed by a 40-week open-label period in which all study participants will take Albuterol Spiromax 90 micrograms (mcg)/inhalation as needed (PRN).
Interventions
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Placebo Spiromax
Placebo as a dry-powder inhaled orally using the Spiromax inhaler. During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
Albuterol Spiromax
Albuterol as a dry-powder inhaled orally using the Spiromax inhaler. Each inhalation delivers 90 micrograms (mcg). During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total dose of 720 micrograms per day for those paricipants randomized to the Albuterol treatment arm.
The double-blind period is followed by a 40-week open-label period in which all study participants will take Albuterol Spiromax 90 micrograms (mcg)/inhalation as needed (PRN).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female subjects who are of childbearing potential (as judged by the investigator) must be currently using and willing to continue to use a medically reliable method of contraception for the entire study duration
* General good health
* Capable of understanding the requirements, risks, and benefits of study participation
* Non-smoker for at least one year prior to the screening visit and a maximum pack-year smoking history of 10 years
* Other criteria apply
Exclusion Criteria
* Participation in any investigational drug trial within 30 days preceding the screening visit
* 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 (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which is not resolved within 1 week prior to the Screening Visit.
* Use of any protocol prohibited concomitant medications for asthma or any protocol prohibited concomitant non-asthma medications
* Inability to tolerate or unwillingness to comply with the protocol requirements.
* History of life-threatening asthma
* Any asthma exacerbation within 3 months of the Screening Visit requiring oral or systemic corticosteroids
* History of life-threatening asthma
* Other criteria apply
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 Clinical Study Site
Scottsdale, Arizona, United States
Teva Clinical Study Site
Los Angeles, California, United States
Teva Clinical Study Site
San Diego, California, United States
Teva Clinical Study Site
Centennial, Colorado, United States
Teva Clinical Study Site
Denver, Colorado, United States
Teva Clinical Study Site
Miami, Florida, United States
Teva Clinical Study Site
Gainesville, Georgia, United States
Teva Clinical Study Site
Louisville, Kentucky, United States
Teva Clinical Study Site
Wheaton, Maryland, United States
Teva Clinical Study Site
Minneapolis, Minnesota, United States
Teva Clinical Study Site
Plymouth, Minnesota, United States
Teva Clinical Study Site
St Louis, Missouri, United States
Teva Clinical Study Site
Bellevue, Nebraska, United States
Teva Clinical Study Site
Boys Town, Nebraska, United States
Teva Clinical Study Site
Skillman, New Jersey, United States
Teva Clinical Study Site
Rochester, New York, United States
Teva Clinical Study Site
Rockville Centre, New York, United States
Teva Clinical Study Site
High Point, North Carolina, United States
Teva Clinical Study Site
Raleigh, North Carolina, United States
Teva Clinical Study Site
Canton, Ohio, United States
Teva Clinical Study Site
Cincinnati, Ohio, United States
Teva Clinical Study Site
Sylvania, Ohio, United States
Teva Clinical Study Site
Eugene, Oregon, United States
Teva Clinical Study Site
Portland, Oregon, United States
Teva Clinical Study Site
El Paso, Texas, United States
Teva Clinical Study Site
New Braunfels, Texas, United States
Teva Clinical Study Site
San Antonio, Texas, United States
Teva Clinical Study Site
Burke, Virginia, United States
Teva Clinical Study Site
Seattle, Washington, United States
Teva Clinical Study Site
Greenfield, Wisconsin, United States
Countries
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Other Identifiers
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ABS-AS-306
Identifier Type: -
Identifier Source: org_study_id
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