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

Primary Purpose

Asthma

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
90 mcg Reference Product
180 mcg Reference Product
90 mcg Test Product
Sponsored by
Amneal Ireland Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Amneal Pharmaceuticals LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Experimental

Arm Label

Placebo Product

90 mcg Reference Product

180 mcg Reference Product

90 mcg Test Product

Arm Description

One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols

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

One actuation each from two different Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 6, 2018
Last Updated
June 13, 2018
Sponsor
Amneal Ireland Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03549897
Brief Title
Bronchoprovocation Study to Evaluate the Pharmacodynamics of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amneal Ireland Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Product
Arm Type
Placebo Comparator
Arm Description
One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols
Arm Title
90 mcg Reference Product
Arm Type
Active Comparator
Arm Description
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
Arm Title
180 mcg Reference Product
Arm Type
Active Comparator
Arm Description
One actuation each from two different Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols
Arm Title
90 mcg Test Product
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Product
Intervention Type
Drug
Intervention Name(s)
90 mcg Reference Product
Other Intervention Name(s)
Albuterol
Intervention Description
90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]
Intervention Type
Drug
Intervention Name(s)
180 mcg Reference Product
Other Intervention Name(s)
Albuterol
Intervention Description
180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]
Intervention Type
Drug
Intervention Name(s)
90 mcg Test Product
Other Intervention Name(s)
Albuterol
Intervention Description
90 mcg Test Product - ALBUTEROL SULFATE HFA [AMNEAL IRELAND LIMITED]
Primary Outcome Measure Information:
Title
Primary Pharmacodynamic Endpoint Post-dose PC20
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irshad Haque
Phone
631-952-0214
Email
ihaque@amneal.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irshad Haque
Organizational Affiliation
Amneal Pharmaceuticals, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Amneal Pharmaceuticals LLC
City
Brookhaven
State/Province
New York
ZIP/Postal Code
11719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irshad Haque
Phone
631-952-0214
Email
ihaque@amneal.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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