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

November 20, 2020 updated by: Lupin, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Huntington Beach, California, United States, 92647
        • Investigational Research Center Site #110
      • Mission Viejo, California, United States, 92691
        • Investigational Research Center Site #114
      • Rolling Hills Estates, California, United States, 90274
        • Investigational Research Center Site #113
      • San Diego, California, United States, 92123
        • Investigational Research Center Site #112
      • San Jose, California, United States, 95117
        • Investigational Research Center Site #116
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Investigational Research Center Site #106
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Investigational Research Center Site #109
      • Bethesda, Maryland, United States, 20814
        • Investigational Research Center Site #105
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Investigational Research Center Site #103
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Investigational Research Center Site #108
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
        • Investigational Research Center Site #115
    • New Jersey
      • Skillman, New Jersey, United States, 08558
        • Investigational Research Center Site #104
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Investigational Research Center Site #102
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Investigational Research Center Site #111
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Investigational Research Center Site #118
    • Oregon
      • Medford, Oregon, United States, 97504
        • Investigational Research Center Site #101
      • Portland, Oregon, United States, 97202
        • Investigational Research Center Site #107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo dose
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
Other: methacholine chloride
Drug: placebo ProAir HFA
Drug: placebo Lupin albuterol HFA MDI
Active Comparator: 90 mcg 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
Other: methacholine chloride
Drug: placebo ProAir HFA
Drug: placebo Lupin albuterol HFA MDI
Drug: ProAir HFA
Active Comparator: 180 mcg 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
Other: methacholine chloride
Drug: placebo Lupin albuterol HFA MDI
Drug: ProAir HFA
Experimental: 90 mcg 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
Other: methacholine chloride
Drug: placebo ProAir HFA
Drug: placebo Lupin albuterol HFA MDI
Drug: Lupin albuterol HFA MDI
Experimental: 180 mcg 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
Other: methacholine chloride
Drug: placebo ProAir HFA
Drug: Lupin albuterol HFA MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-dose PC20 Concentration After Receiving Differing Doses of Test, Reference, or Placebo
Time Frame: 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.
Post-dose at Visits 2-6 of the study, a total of approximately 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lupin, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS-MDI-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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