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Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma

Primary Purpose

Mild Persistent Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
methacholine chloride
placebo ProAir HFA
ProAir HFA
Lupin albuterol HFA MDI
placebo Lupin albuterol HFA MDI
Sponsored by
Lupin, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Persistent Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • Investigational Research Center Site #110
  • Investigational Research Center Site #114
  • Investigational Research Center Site #113
  • Investigational Research Center Site #112
  • Investigational Research Center Site #116
  • Investigational Research Center Site #106
  • Investigational Research Center Site #109
  • Investigational Research Center Site #105
  • Investigational Research Center Site #103
  • Investigational Research Center Site #108
  • Investigational Research Center Site #115
  • Investigational Research Center Site #104
  • Investigational Research Center Site #102
  • Investigational Research Center Site #111
  • Investigational Research Center Site #118
  • Investigational Research Center Site #101
  • Investigational Research Center Site #107

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Placebo dose

90 mcg ProAir HFA

180 mcg ProAir HFA

90 mcg Lupin albuterol HFA MDI

180 mcg Lupin albuterol HFA MDI

Arm Description

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 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 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 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 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 12, 2015
Last Updated
November 20, 2020
Sponsor
Lupin, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02584257
Brief Title
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lupin, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Persistent Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo dose
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
90 mcg ProAir HFA
Arm Type
Active Comparator
Arm Description
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
Arm Title
180 mcg ProAir HFA
Arm Type
Active Comparator
Arm Description
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
Arm Title
90 mcg Lupin albuterol HFA MDI
Arm Type
Experimental
Arm Description
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
Arm Title
180 mcg Lupin albuterol HFA MDI
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
methacholine chloride
Intervention Type
Drug
Intervention Name(s)
placebo ProAir HFA
Intervention Type
Drug
Intervention Name(s)
ProAir HFA
Intervention Type
Drug
Intervention Name(s)
Lupin albuterol HFA MDI
Intervention Type
Drug
Intervention Name(s)
placebo Lupin albuterol HFA MDI
Primary Outcome Measure Information:
Title
Post-dose PC20 Concentration After Receiving Differing Doses of Test, Reference, or Placebo
Description
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.
Time Frame
Post-dose at Visits 2-6 of the study, a total of approximately 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Facility Information:
Facility Name
Investigational Research Center Site #110
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Investigational Research Center Site #114
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Investigational Research Center Site #113
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Investigational Research Center Site #112
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Investigational Research Center Site #116
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Investigational Research Center Site #106
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Investigational Research Center Site #109
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Investigational Research Center Site #105
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Investigational Research Center Site #103
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Investigational Research Center Site #108
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Investigational Research Center Site #115
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Investigational Research Center Site #104
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Investigational Research Center Site #102
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Investigational Research Center Site #111
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Investigational Research Center Site #118
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Investigational Research Center Site #101
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Investigational Research Center Site #107
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma

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