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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03549897
• Other study ID #: AI-ABL-001
• Status: Recruiting
• Phase: Phase 3
• Start date: March 16, 2018
• Est. completion date: September 2018

Study information

• Verified date: June 2018
• Source: Amneal Ireland Limited
• Contact: Irshad Haque
• Phone: 631-952-0214
• Email: ihaque[@]amneal.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2018
• Est. primary completion date: August 2018
• 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.

• 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Placebo
Placebo Product
• 90 mcg Reference Product
90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]
• 180 mcg Reference Product
180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]
• 90 mcg Test Product
90 mcg Test Product - ALBUTEROL SULFATE HFA [AMNEAL IRELAND LIMITED]

Locations

Country	Name	City	State
United States	Amneal Pharmaceuticals LLC	Brookhaven	New York

Sponsors (1)

Lead Sponsor	Collaborator
Amneal Ireland Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Pharmacodynamic Endpoint Post-dose PC20	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.	6 weeks