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

Phase 3

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: 90 mcg Reference Product; Drug: 180 mcg Reference Product; Drug: 90 mcg Test Product

• Registration Number: NCT03549897
• Lead Sponsor: Amneal Ireland Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-16
• Study First Submitted: 2018-04-06
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-08
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-06-14
• Primary Completion: 2018-08
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Product	Placebo	One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols
90 mcg Reference Product	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
180 mcg Reference Product	180 mcg Reference Product	One actuation each from two different Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols
90 mcg Test Product	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

Primary Outcome Measures

Name	Time	Method
Primary Pharmacodynamic Endpoint Post-dose PC20	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.

Trial Locations

Locations (1)

Amneal Pharmaceuticals LLC; 🇺🇸 Brookhaven, New York, United States