Overview

This trial is active, not recruiting.

Condition mild persistent asthma
Treatments methacholine chloride, placebo dose, 90 mcg reference product, 180 mcg of reference product, 90 mcg of test product, 180 mcg of test product
Phase phase 3
Sponsor Lupin, Inc.
Start date April 2016
End date August 2016
Trial size 91 participants
Trial identifier NCT02584257, AS-MDI-301

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo dose: 1 actuation each from 2 different placebo Reference inhalation aerosols and one actuation each from 2 different placebo Test inhalation aerosols
methacholine chloride
placebo dose
(Active Comparator)
90 mcg of Reference product: 1 actuation each from the Reference product inhalation aerosol and the placebo Reference inhalation aerosol and 1 actuation each from 2 different placebo Test product inhalation aerosols
methacholine chloride
90 mcg reference product
(Active Comparator)
180 mcg of Reference: 1 actuation each from 2 different Reference inhalation aerosols and 1 actuation each from 2 different placebo Test product inhalation aerosols
methacholine chloride
180 mcg of reference product
(Experimental)
90 mcg of Test product: 1 actuation each from the Test product inhalation aerosol and the placebo Test inhalation aerosol and 1 actuation each from 2 different placebo Reference inhalation aerosols
methacholine chloride
90 mcg of test product
(Experimental)
180 mcg of Test product: 1 actuation each from 2 different Test product inhalation aerosols and 1 actuation each from 2 different placebo Reference product inhalation aerosols
methacholine chloride
180 mcg of test product

Primary Outcomes

Measure
Provocative Concentration of Methacholine Causing 20 % Fall (PC20) in FEV1(Forced Expiratory Volume in 1 second)
time frame: Following a single dose on day 1

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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).

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Lupin Ltd..