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

NCT03562949 | Terminated Phase 3 FDA Drug

• 1 other identifier: AI-BDP-001
• Study Type: interventional
• Target: 761
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number and type of adverse events

  Minimum of a 2-week run-in period followed by a 4-week treatment period

Study Arms (3)

Test Product

EXPERIMENTAL

Test Product, 40 mcg, 2 x daily

Drug: Test Product

Reference Product

ACTIVE COMPARATOR

Reference Product, 40 mcg, 2 x daily

Drug: Reference Product

Placebo

PLACEBO COMPARATOR

Placebo Product 2 x daily

Drug: Placebo

Interventions

Test Product DRUG

Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg

Test Product

Reference Product DRUG

QVAR® 40 mcg (Beclomethasone Dipropionate HFA)

Also known as: QVAR

Reference Product

Placebo DRUG

Placebo Product

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amneal Ireland Limited: lead

Study Sites (12)

Beach Clinical Research, Inc.

Huntington Beach, California, 92647, United States

Location

Downtown La Research Center

Los Angeles, California, 90017, United States

Location

Moonshine Research Center

Doral, Florida, 33166, United States

Location

Hope Clinical Trials, Inc.

Miami, Florida, 33165, United States

Location

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014, United States

Location

Advanced Research for Health Improvement

Naples, Florida, 34102, United States

Location

Florida Institute for Clinical Research

Orlando, Florida, 32825, United States

Location

Innovation Research Center

Palmetto Bay, Florida, 33157, United States

Location

Florida Premier Research Institute

Winter Park, Florida, 32789, United States

Location

Monroe BioMedical Research

Monroe, North Carolina, 28112, United States

Location

TTS Research

Boerne, Texas, 78006, United States

Location

PCP for Life/ Mercury Clinical Research

Splendora, Texas, 77372, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Irshad Haque

  Amneal Pharmaceuticals, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 20, 2018
• Study Start: December 6, 2018
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (12)