Bronchoprovocation Study to Evaluate the Pharmacodynamics of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base
NCT ID: NCT03549897
Last Updated: 2018-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2018-03-16
2018-09-30
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
DOUBLE
Study Groups
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Placebo Product
One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols
Placebo
Placebo Product
90 mcg Reference Product
One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols
90 mcg Reference Product
90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]
180 mcg Reference Product
One actuation each from two different Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols
180 mcg Reference Product
180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]
90 mcg Test Product
One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols
90 mcg Test Product
90 mcg Test Product - ALBUTEROL SULFATE HFA \[AMNEAL IRELAND LIMITED\]
Interventions
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Placebo
Placebo Product
90 mcg Reference Product
90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]
180 mcg Reference Product
180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE \[TEVA RESPIRATORY, LLC\]
90 mcg Test Product
90 mcg Test Product - ALBUTEROL SULFATE HFA \[AMNEAL IRELAND LIMITED\]
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
* FEV1 ≥ 80% of predicted.
* Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg/mL.
* Nonsmokers for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
* Written informed consent
Exclusion Criteria
* History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
* History of cystic fibrosis, bronchiectasis or other respiratory diseases.
* History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease.
* Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.
* Known intolerance or hypersensitivity to any component of the albuterol MDI.
18 Years
65 Years
ALL
No
Sponsors
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Amneal Ireland Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Irshad Haque
Role: STUDY_DIRECTOR
Amneal Pharmaceuticals, LLC
Locations
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Amneal Pharmaceuticals LLC
Brookhaven, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AI-ABL-001
Identifier Type: -
Identifier Source: org_study_id
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