Bronchoprovocation Study to Evaluate the Pharmacodynamics of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base

• ClinicalTrials.gov Identifier: NCT03549897
• Recruitment Status: Unknown
• First Posted: June 8, 2018
• Last Update Posted: June 14, 2018
• Sponsor: Amneal Ireland Limited
• Information provided by (Responsible Party): Amneal Ireland Limited

Study Description

Brief Summary:

This randomized, single-dose, double-blind, double-dummy, four-period, four-sequence, four-treatment, placebo and active controlled, comparative, multiple-center, crossover-design bronchoprovocation study has been designed to evaluate the pharmacodynamic equivalence of albuterol sulfate HFA inhalation aerosol, eq 90 mcg base (Amneal Ireland Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in patients with stable mild asthma.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Placebo; Drug: 90 mcg Reference Product; Drug: 180 mcg Reference Product; Drug: 90 mcg Test Product	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Four-Sequence, Four-Treatment, Placebo and Active Controlled, Comparative, Multiple-Center, Crossover-Design, Bronchoprovocation Study to Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Amneal Ireland Limited) to PROAIR® HFA (Albuterol Sulfate) Inhalation Aerosol, eq 90 mcg Base (Teva Respiratory, LLC) in Patients With Stable, Mild Asthma
• Actual Study Start Date: March 16, 2018
• Estimated Primary Completion Date: August 2018
• Estimated Study Completion Date: September 2018

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo Product; One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols	Drug: Placebo; Placebo Product
Active Comparator: 90 mcg Reference Product; One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols	Drug: 90 mcg Reference Product; 90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]; Other Name: Albuterol
Active Comparator: 180 mcg Reference Product; One actuation each from two different Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols	Drug: 180 mcg Reference Product; 180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]; Other Name: Albuterol
Experimental: 90 mcg Test Product; One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols	Drug: 90 mcg Test Product; 90 mcg Test Product - ALBUTEROL SULFATE HFA [AMNEAL IRELAND LIMITED]; Other Name: Albuterol

Outcome Measures

Primary Outcome Measures :

1. Primary Pharmacodynamic Endpoint Post-dose PC20 [ Time Frame: 6 weeks ]
   Provocative concentration of the methacholine challenge agent required to reduce the FEV1 by 20% following administration of differing doses of albuterol or placebo by inhalation. The 20% reduction in FEV1 will be determined relative to the post-saline FEV1 measure before the placebo or albuterol administration.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.
• FEV1 ≥ 80% of predicted.
• Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg/mL.
• Nonsmokers for at least six months 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:

• Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
• History of seasonal asthma exacerbations, in which case the subject 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, including ECG with evidence of ischemic heart disease.
• Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.
• Known intolerance or hypersensitivity to any component of the albuterol MDI.

Contacts and Locations

Contacts

Contact: Irshad Haque; 631-952-0214; ihaque@amneal.com

Locations

United States, New York

Amneal Pharmaceuticals LLC; Recruiting

Brookhaven, New York, United States, 11719

Contact: Irshad Haque 631-952-0214 ihaque@amneal.com

Sponsors and Collaborators

Amneal Ireland Limited

Investigators

• Study Director: Irshad Haque; Amneal Pharmaceuticals, LLC

More Information

• Responsible Party: Amneal Ireland Limited
• ClinicalTrials.gov Identifier: NCT03549897
• Other Study ID Numbers: AI-ABL-001
• First Posted: June 8, 2018
• Last Update Posted: June 14, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Albuterol; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Tocolytic Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action