Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
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
1 other identifier
interventional
217
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2016
Shorter than P25 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
November 18, 2020
CompletedDecember 4, 2020
November 1, 2020
4 months
October 12, 2015
September 24, 2020
November 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Post-dose PC20 Concentration After Receiving Differing Doses of Test, Reference, or Placebo
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.
Post-dose at Visits 2-6 of the study, a total of approximately 4 weeks.
Study Arms (5)
Placebo dose
PLACEBO COMPARATORPlacebo 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
ACTIVE COMPARATOR90 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
ACTIVE COMPARATOR180 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
EXPERIMENTAL90 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
EXPERIMENTAL180 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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lupin, Inc.lead
Study Sites (17)
Investigational Research Center Site #110
Huntington Beach, California, 92647, United States
Investigational Research Center Site #114
Mission Viejo, California, 92691, United States
Investigational Research Center Site #113
Rolling Hills Estates, California, 90274, United States
Investigational Research Center Site #112
San Diego, California, 92123, United States
Investigational Research Center Site #116
San Jose, California, 95117, United States
Investigational Research Center Site #106
Tallahassee, Florida, 32308, United States
Investigational Research Center Site #109
Baltimore, Maryland, 21236, United States
Investigational Research Center Site #105
Bethesda, Maryland, 20814, United States
Investigational Research Center Site #103
North Dartmouth, Massachusetts, 02747, United States
Investigational Research Center Site #108
St Louis, Missouri, 63141, United States
Investigational Research Center Site #115
Bellevue, Nebraska, 68123, United States
Investigational Research Center Site #104
Skillman, New Jersey, 08558, United States
Investigational Research Center Site #102
Raleigh, North Carolina, 27607, United States
Investigational Research Center Site #111
Cincinnati, Ohio, 45231, United States
Investigational Research Center Site #118
Tulsa, Oklahoma, 74136, United States
Investigational Research Center Site #101
Medford, Oregon, 97504, United States
Investigational Research Center Site #107
Portland, Oregon, 97202, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mark Lepore
- Organization
- Lupin Research Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2015
First Posted
October 22, 2015
Study Start
April 1, 2016
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
December 4, 2020
Results First Posted
November 18, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share