Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
This trial is active, not recruiting.
|Condition||mild persistent asthma|
|Treatments||methacholine chloride, placebo dose, 90 mcg reference product, 180 mcg of reference product, 90 mcg of test product, 180 mcg of test product|
|Start date||April 2016|
|End date||August 2016|
|Trial size||91 participants|
|Trial identifier||NCT02584257, AS-MDI-301|
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Huntington Beach, CA||Investigational Research Center Site #110||no longer recruiting|
|Mission Viego, CA||Investigational Research Center Site #114||no longer recruiting|
|Rolling Hills Estates, CA||Investigational Research Center Site #113||no longer recruiting|
|San Diego, CA||Investigational Research Center Site #112||no longer recruiting|
|San Jose, CA||Investigational Research Center Site #116||no longer recruiting|
|Tallahassee, FL||Investigational Research Center Site #106||no longer recruiting|
|Baltimore, MD||Investigational Research Center Site #109||no longer recruiting|
|Bethesda, MD||Investigational Research Center Site #105||no longer recruiting|
|North Dartmouth, MA||Investigational Research Center Site #103||no longer recruiting|
|St. Louis, MO||Investigational Research Center Site #108||no longer recruiting|
|Bellevue, NE||Investigational Research Center Site #115||no longer recruiting|
|Skillman, NJ||Investigational Research Center Site #104||no longer recruiting|
|Raleigh, NC||Investigational Research Center Site #102||no longer recruiting|
|Cincinnati, OH||Investigational Research Center Site #111||no longer recruiting|
|Tulsa, OK||Investigational Research Center Site #118||no longer recruiting|
|Medford, OR||Investigational Research Center Site #101||no longer recruiting|
|Portland, OR||Investigational Research Center Site #107||no longer recruiting|
|Endpoint classification||bio-equivalence study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver)|
Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)
time frame: Following a single dose on day 1
Male or female participants from 18 years up to 65 years old.
- Male and non-pregnant female subjects (18-65 years of age)
- Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
- Forced Expiratory Volume in 1 second ( FEV1) ≥ 80% of predicted. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.
- Nonsmokers for at least 1 year 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.
- Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper respiratory tract infection, lower respiratory tract, viral bronchitis and/or sinobronchitis) within six weeks preceding the screening visit.
- History of seasonal asthma exacerbations, in which case the patient 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, or chronic condition that could put the safety of the patient at risk during the study or affect the efficacy and safety analyses during the study.
- Treatment in an emergency room, urgent care center, or hospitalization for acute asthmatic symptoms within the past 6 months or need for daily oral corticosteroids within past 3 months.
- Known intolerance or hypersensitivity to any component of the albuterol metered dose inhaler (MDI).
|Official title||Comparison of the Pharmacodynamic Profile of Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Bronchoprovocation in Adult Patients With Stable Mild Asthma|
|Description||A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, 5-Treatment, Randomized, Crossover Study to Demonstrate the Pharmacodynamic Bioequivalence of Test and Reference Metered Dose Inhalers containing Albuterol Sulfate using Bronchoprovocation in Adult Patients with Stable Mild Asthma|
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