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

NCT ID: NCT02584257

Last Updated: 2020-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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

Conditions

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Mild Persistent Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type PLACEBO_COMPARATOR

methacholine chloride

Intervention Type OTHER

placebo ProAir HFA

Intervention Type DRUG

placebo Lupin albuterol HFA MDI

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

methacholine chloride

Intervention Type OTHER

placebo ProAir HFA

Intervention Type DRUG

ProAir HFA

Intervention Type DRUG

placebo Lupin albuterol HFA MDI

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

methacholine chloride

Intervention Type OTHER

ProAir HFA

Intervention Type DRUG

placebo Lupin albuterol HFA MDI

Intervention Type DRUG

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

Group Type EXPERIMENTAL

methacholine chloride

Intervention Type OTHER

placebo ProAir HFA

Intervention Type DRUG

Lupin albuterol HFA MDI

Intervention Type DRUG

placebo Lupin albuterol HFA MDI

Intervention Type DRUG

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

Group Type EXPERIMENTAL

methacholine chloride

Intervention Type OTHER

placebo ProAir HFA

Intervention Type DRUG

Lupin albuterol HFA MDI

Intervention Type DRUG

Interventions

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methacholine chloride

Intervention Type OTHER

placebo ProAir HFA

Intervention Type DRUG

ProAir HFA

Intervention Type DRUG

Lupin albuterol HFA MDI

Intervention Type DRUG

placebo Lupin albuterol HFA MDI

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lupin, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational Research Center Site #110

Huntington Beach, California, United States

Site Status

Investigational Research Center Site #114

Mission Viejo, California, United States

Site Status

Investigational Research Center Site #113

Rolling Hills Estates, California, United States

Site Status

Investigational Research Center Site #112

San Diego, California, United States

Site Status

Investigational Research Center Site #116

San Jose, California, United States

Site Status

Investigational Research Center Site #106

Tallahassee, Florida, United States

Site Status

Investigational Research Center Site #109

Baltimore, Maryland, United States

Site Status

Investigational Research Center Site #105

Bethesda, Maryland, United States

Site Status

Investigational Research Center Site #103

North Dartmouth, Massachusetts, United States

Site Status

Investigational Research Center Site #108

St Louis, Missouri, United States

Site Status

Investigational Research Center Site #115

Bellevue, Nebraska, United States

Site Status

Investigational Research Center Site #104

Skillman, New Jersey, United States

Site Status

Investigational Research Center Site #102

Raleigh, North Carolina, United States

Site Status

Investigational Research Center Site #111

Cincinnati, Ohio, United States

Site Status

Investigational Research Center Site #118

Tulsa, Oklahoma, United States

Site Status

Investigational Research Center Site #101

Medford, Oregon, United States

Site Status

Investigational Research Center Site #107

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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AS-MDI-301

Identifier Type: -

Identifier Source: org_study_id