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

NCT ID: NCT03562949

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 761 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-06
• Study Completion Date: 2019-08-02

Brief Summary

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test Product

Test Product, 40 mcg, 2 x daily

Group Type: EXPERIMENTAL

Test Product

Intervention Type: DRUG

Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg

Reference Product

Reference Product, 40 mcg, 2 x daily

Group Type: ACTIVE_COMPARATOR

Reference Product

Intervention Type: DRUG

QVAR® 40 mcg (Beclomethasone Dipropionate HFA)

Placebo

Placebo Product 2 x daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Product

Interventions

Test Product

Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg

Intervention Type: DRUG

Reference Product

QVAR® 40 mcg (Beclomethasone Dipropionate HFA)

Intervention Type: DRUG

Placebo

Placebo Product

Intervention Type: DRUG

Other Intervention Names

QVAR

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amneal Ireland Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Irshad Haque

Role: STUDY_DIRECTOR

Amneal Pharmaceuticals, LLC

Locations

Beach Clinical Research, Inc.

Huntington Beach, California, United States

Downtown La Research Center

Los Angeles, California, United States

Moonshine Research Center

Doral, Florida, United States

Hope Clinical Trials, Inc.

Miami, Florida, United States

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, United States

Advanced Research for Health Improvement

Naples, Florida, United States

Florida Institute for Clinical Research

Orlando, Florida, United States

Innovation Research Center

Palmetto Bay, Florida, United States

Florida Premier Research Institute

Winter Park, Florida, United States

Monroe BioMedical Research

Monroe, North Carolina, United States

TTS Research

Boerne, Texas, United States

PCP for Life/ Mercury Clinical Research

Splendora, Texas, United States

Countries

United States

Other Identifiers

AI-BDP-001

Identifier Type: -

Identifier Source: org_study_id