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

Mild Persistent Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584257
• Other study ID #: AS-MDI-301
• Status: Completed
• Phase: Phase 3
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2020
• Source: Lupin Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Asthma
• Mild Persistent Asthma

Intervention

Other:
• methacholine chloride

Drug:
• placebo ProAir HFA

• ProAir HFA

• Lupin albuterol HFA MDI

• placebo Lupin albuterol HFA MDI

Locations

Country	Name	City	State
United States	Investigational Research Center Site #109	Baltimore	Maryland
United States	Investigational Research Center Site #115	Bellevue	Nebraska
United States	Investigational Research Center Site #105	Bethesda	Maryland
United States	Investigational Research Center Site #111	Cincinnati	Ohio
United States	Investigational Research Center Site #110	Huntington Beach	California
United States	Investigational Research Center Site #101	Medford	Oregon
United States	Investigational Research Center Site #114	Mission Viejo	California
United States	Investigational Research Center Site #103	North Dartmouth	Massachusetts
United States	Investigational Research Center Site #107	Portland	Oregon
United States	Investigational Research Center Site #102	Raleigh	North Carolina
United States	Investigational Research Center Site #113	Rolling Hills Estates	California
United States	Investigational Research Center Site #108	Saint Louis	Missouri
United States	Investigational Research Center Site #112	San Diego	California
United States	Investigational Research Center Site #116	San Jose	California
United States	Investigational Research Center Site #104	Skillman	New Jersey
United States	Investigational Research Center Site #106	Tallahassee	Florida
United States	Investigational Research Center Site #118	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Lupin, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.