A BE Study to Compare Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg and QVAR® 40 mcg, Inhalation Aerosol

A Randomized, Multiple-Dose, Placebo-Controlled, Multi-Center Study Comparing Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg to QVAR® 40 mcg (Beclomethasone Dipropionate HFA), Inhalation Aerosol in Treatment of Subjects With Asthma

To compare the efficacy and safety profiles of Beclomethasone dipropionate Inhalation Aerosol, 40 mcg (test product) and QVAR 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol (reference product) and to demonstrate that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Test Product; Drug: Reference Product

• Study Type: Interventional
• Enrollment (Actual): 761
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Beach, California, United States, 92647
      • Beach Clinical Research, Inc.
    • Los Angeles, California, United States, 90017
      • Downtown LA Research Center
  • Florida
    • Doral, Florida, United States, 33166
      • Moonshine Research Center
    • Miami, Florida, United States, 33165
      • Hope Clinical Trials, Inc.
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic, Inc.
    • Naples, Florida, United States, 34102
      • Advanced Research for Health Improvement
    • Orlando, Florida, United States, 32825
      • Florida Institute For Clinical Research
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Research Center
    • Winter Park, Florida, United States, 32789
      • Florida Premier Research Institute
  • North Carolina
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
  • Texas
    • Boerne, Texas, United States, 78006
      • TTS research
    • Splendora, Texas, United States, 77372
      • PCP for Life/ Mercury Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult male or female subjects of non-childbearing or of childbearing potential committing to consistent and correct use of an acceptable method of birth control.
• Diagnosis of asthma as defined by the National Asthma Education and Prevention Program at least 12 months prior to screening.
• Pre-bronchodilator FEV1 of >45% and <85% of predicted value during the screening visit and on the first day of treatment.
• >15% and >0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI).
• Patients should be stable on their chronic asthma treatment regimen for at least four weeks prior to enrollment.
• Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and having had <10 pack-years of historical use.
• Ability to replace current short-acting β agonist (SABAs) with salbutamol/albuterol inhaler for use as needed for the duration of the study. Subjects should be able to withhold all inhaled SABAs for at least six hours prior to lung function assessments on study visits.
• Ability to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for remainder of the study.
• Willingness to give their written informed consent to participate in the study.

Exclusion Criteria:

• Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year prior to the screening or during the run-in period.
• Significant respiratory disease other than asthma (COPD, interstitial lung disease, etc.)
• Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that, in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.
• Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within four weeks prior to the screening, during the run-in period, or on the day of treatment.
• Hypersensitivity to any sympathomimetic drug (e.g., albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
• Patients receiving β2-blockers, anti-arrhythmics, anti-depressants, and monoamine oxidase inhibitors within 4 weeks prior to the screening.
• Patients who required systemic corticosteroids (for any reason) within the past 2 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Product; Test Product, 40 mcg, 2 x daily	Drug: Test Product; Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
Active Comparator: Reference Product; Reference Product, 40 mcg, 2 x daily	Drug: Reference Product; QVAR® 40 mcg (Beclomethasone Dipropionate HFA); Other Names: QVAR
Placebo Comparator: Placebo; Placebo Product 2 x daily	Drug: Placebo; Placebo Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline-adjusted, pre-dose FEV1 on the last day of the 4-week treatment period	FEV1 measured in the morning prior dosing of inhaled medications on the last day of the 4-week treatment. The primary endpoint should be baseline adjusted (change from baseline).	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and type of adverse events	To investigate the safety and tolerability of Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg and QVAR® 40 mcg, Inhalation Aerosol in the target population.	Minimum of a 2-week run-in period followed by a 4-week treatment period

Collaborators and Investigators

• Sponsor: Amneal Ireland Limited
• Investigators: Study Director: Irshad Haque, Amneal Pharmaceuticals, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2018
• Primary Completion (Actual): August 2, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Respiratory Aspiration; Asthma
• Other Study ID Numbers: AI-BDP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes