A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma
NCT ID: NCT01058863
Last Updated: 2021-11-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2010-02-28
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Albuterol Spiromax® 90 mcg
A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
Albuterol Spiromax®
Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
Albuterol Spiromax® 180 mcg
A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
Albuterol Spiromax®
Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
ProAir® HFA 90 mcg
A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
ProAir® HFA
ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
ProAir® HFA 180 mcg
A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
ProAir® HFA
ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
Placebo Inhaler
Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
Interventions
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Albuterol Spiromax®
Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
ProAir® HFA
ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Placebo Inhaler
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be between 12 years of age and older,
* Male or Female, females of non-child bearing potential or using reliable contraception
* Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180 mcg albuterol
* Stable low dose of Inhaled Corticosteroids
* Non-smoker, 12 months smoking-free and \<=10-pack years history
* Otherwise healthy
* Other criteria apply
Exclusion Criteria
* Allergic to albuterol or severe milk protein allergy
* Must not be on another trial for 30days.
* 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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Teva Study Leader
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Clinical Study Site
Huntington Beach, California, United States
Teva Clinical Study Site
Rolling Hills Est., California, United States
Teva Clinical Study Site
San Diego, California, United States
Teva Clinical Study Site
Colorado Springs, Colorado, United States
Teva Clinical Study Site
Margate, Florida, United States
Teva Clinical Study Site
Miami, Florida, United States
Teva Clinical Study Site
St Louis, Missouri, United States
Teva Clinical Study Site
Skillman, New Jersey, United States
Teva Clinical Study Site
Raleigh, North Carolina, United States
Teva Clinical Study Site
Cincinnati, Ohio, United States
Teva Clinical Study Site
Dayton, Ohio, United States
Teva Clinical Study Site
Medford, Oregon, United States
Teva Clinical Study Site
Portland, Oregon, United States
Countries
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Other Identifiers
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ABS-AS-201
Identifier Type: -
Identifier Source: org_study_id