Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
- Conditions
- Mild Persistent Asthma
- Interventions
- Other: methacholine chlorideDrug: placebo ProAir HFA
- Registration Number
- NCT02584257
- Lead Sponsor
- Lupin, Inc.
- Brief Summary
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.
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 180 mcg ProAir HFA placebo Lupin albuterol HFA MDI 180 mcg of ProAir HFA: 1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols 90 mcg Lupin albuterol HFA MDI placebo Lupin albuterol HFA MDI 90 mcg of Lupin albuterol HFA MDI product: 1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols 180 mcg Lupin albuterol HFA MDI Lupin albuterol HFA MDI 180 mcg of Lupin albuterol HFA MDI: 1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols Placebo dose placebo ProAir HFA Placebo dose: 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and one actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols 90 mcg ProAir HFA methacholine chloride 90 mcg of ProAir HFA: 1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols 180 mcg ProAir HFA ProAir HFA 180 mcg of ProAir HFA: 1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols Placebo dose methacholine chloride Placebo dose: 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and one actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols 90 mcg ProAir HFA placebo ProAir HFA 90 mcg of ProAir HFA: 1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols 90 mcg Lupin albuterol HFA MDI placebo ProAir HFA 90 mcg of Lupin albuterol HFA MDI product: 1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols 90 mcg Lupin albuterol HFA MDI Lupin albuterol HFA MDI 90 mcg of Lupin albuterol HFA MDI product: 1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols 90 mcg Lupin albuterol HFA MDI methacholine chloride 90 mcg of Lupin albuterol HFA MDI product: 1 actuation each from the Lupin albuterol HFA MDI inhalation aerosol and the placebo Lupin albuterol HFA MDI inhalation aerosol and 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols Placebo dose placebo Lupin albuterol HFA MDI Placebo dose: 1 actuation each from 2 different placebo ProAir HFA inhalation aerosols and one actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols 180 mcg Lupin albuterol HFA MDI methacholine chloride 180 mcg of Lupin albuterol HFA MDI: 1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols 90 mcg ProAir HFA ProAir HFA 90 mcg of ProAir HFA: 1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols 90 mcg ProAir HFA placebo Lupin albuterol HFA MDI 90 mcg of ProAir HFA: 1 actuation each from ProAir HFA inhalation aerosol and the placebo ProAir HFA inhalation aerosol and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols 180 mcg ProAir HFA methacholine chloride 180 mcg of ProAir HFA: 1 actuation each from 2 different ProAir HFA inhalation aerosols and 1 actuation each from 2 different placebo Lupin albuterol HFA MDI inhalation aerosols 180 mcg Lupin albuterol HFA MDI placebo ProAir HFA 180 mcg of Lupin albuterol HFA MDI: 1 actuation each from 2 different Lupin albuterol HFA MDI inhalation aerosols and 1 actuation each from 2 different placebo ProAir HFA product inhalation aerosols
- Primary Outcome Measures
Name Time Method Post-dose PC20 Concentration After Receiving Differing Doses of Test, Reference, or Placebo Post-dose at Visits 2-6 of the study, a total of approximately 4 weeks. The primary efficacy endpoint was the postdose PC20 following administration of differing doses of albuterol (or placebo) by inhalation. The 20% reduction in FEV1 was determined relative to the saline stage FEV1 measured before albuterol or placebo administration. Additionally, an analysis of superiority to placebo was performed for the T and R products prior to the BE determination. In this study the ITT and PP populations were identical.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Investigational Research Center Site #112
🇺🇸San Diego, California, United States
Investigational Research Center Site #111
🇺🇸Cincinnati, Ohio, United States
Investigational Research Center Site #113
🇺🇸Rolling Hills Estates, California, United States
Investigational Research Center Site #114
🇺🇸Mission Viejo, California, United States
Investigational Research Center Site #109
🇺🇸Baltimore, Maryland, United States
Investigational Research Center Site #106
🇺🇸Tallahassee, Florida, United States
Investigational Research Center Site #105
🇺🇸Bethesda, Maryland, United States
Investigational Research Center Site #118
🇺🇸Tulsa, Oklahoma, United States
Investigational Research Center Site #101
🇺🇸Medford, Oregon, United States
Investigational Research Center Site #107
🇺🇸Portland, Oregon, United States
Investigational Research Center Site #103
🇺🇸North Dartmouth, Massachusetts, United States
Investigational Research Center Site #104
🇺🇸Skillman, New Jersey, United States
Investigational Research Center Site #115
🇺🇸Bellevue, Nebraska, United States
Investigational Research Center Site #108
🇺🇸Saint Louis, Missouri, United States
Investigational Research Center Site #110
🇺🇸Huntington Beach, California, United States
Investigational Research Center Site #102
🇺🇸Raleigh, North Carolina, United States
Investigational Research Center Site #116
🇺🇸San Jose, California, United States