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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

Tracking Information
First Submitted Date  ICMJE April 6, 2018
First Posted Date  ICMJE June 8, 2018
Last Update Posted Date June 14, 2018
Actual Study Start Date  ICMJE March 16, 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03549897 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bronchoprovocation Study to Evaluate the Pharmacodynamics of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Placebo
    Placebo Product
  • Drug: 90 mcg Reference Product
    90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]
    Other Name: Albuterol
  • Drug: 180 mcg Reference Product
    180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]
    Other Name: Albuterol
  • Drug: 90 mcg Test Product
    90 mcg Test Product - ALBUTEROL SULFATE HFA [AMNEAL IRELAND LIMITED]
    Other Name: Albuterol
Study Arms  ICMJE
  • 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
    Intervention: Drug: Placebo
  • 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
    Intervention: Drug: 90 mcg Reference Product
  • 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
    Intervention: Drug: 180 mcg Reference Product
  • 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
    Intervention: Drug: 90 mcg Test Product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Irshad Haque 631-952-0214 ihaque@amneal.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03549897
Other Study ID Numbers  ICMJE AI-ABL-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amneal Ireland Limited
Study Sponsor  ICMJE Amneal Ireland Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Irshad Haque Amneal Pharmaceuticals, LLC
PRS Account Amneal Ireland Limited
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP