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

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549897


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

Locations
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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
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Study Director: Irshad Haque Amneal Pharmaceuticals, LLC

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Responsible Party: Amneal Ireland Limited
ClinicalTrials.gov Identifier: NCT03549897     History of Changes
Other Study ID Numbers: AI-ABL-001
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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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