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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03562949
• Other study ID #: AI-BDP-001
• Status: Terminated
• Phase: Phase 3
• Start date: December 6, 2018
• Est. completion date: August 2, 2019

Study information

• Verified date: January 2020
• Source: Amneal Ireland Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 761
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 ß 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 ß 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 ß2-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.

Related Conditions & MeSH terms

• Asthma
• Respiratory Aspiration

Intervention

Drug:
• Test Product
Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
• Reference Product
QVAR® 40 mcg (Beclomethasone Dipropionate HFA)
• Placebo
Placebo Product

Locations

Country	Name	City	State
United States	TTS Research	Boerne	Texas
United States	Moonshine Research Center	Doral	Florida
United States	Beach Clinical Research, Inc.	Huntington Beach	California
United States	Downtown La Research Center	Los Angeles	California
United States	Hope Clinical Trials, Inc.	Miami	Florida
United States	San Marcus Research Clinic, Inc.	Miami Lakes	Florida
United States	Monroe BioMedical Research	Monroe	North Carolina
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	PCP for Life/ Mercury Clinical Research	Splendora	Texas
United States	Florida Premier Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Amneal Ireland Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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