Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH

NCT04051710 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CR176-17
• Study Type: interventional
• Target: 1,550
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the therapeutic equivalence of Beclomethasone Dipropionate MDI (Inhalation Aerosol) 0.04 mg/ INH with the marketed QVAR® 40 mcg (Beclomethasone dipropionate hydrofluoroalkane (HFA)) and to demonstrate superiority of both active treatments over placebo.

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• Change in FEV1 From Pre Dose to End of Treatment

  Mean change in Forced Expiratory volume in 1 second (FEV 1) from baseline to end of study visit

  4 weeks

Study Arms (3)

Group-I (Test)

EXPERIMENTAL

One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Test) twice daily.

Drug: Test Product

Group-II (Reference)

ACTIVE COMPARATOR

One inhalation of QVAR® 40 mcg (Beclomethasone dipropionate HFA), Inhalation Aerosol twice daily.

Drug: Reference Product

Group-III (Placebo)

PLACEBO COMPARATOR

One inhalation of Placebo Inhalation Aerosol twice daily.

Drug: Placebo

Interventions

Test Product DRUG

Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg

Also known as: Test

Group-I (Test)

Reference Product DRUG

Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg

Also known as: QVAR

Group-II (Reference)

Placebo DRUG

Placebo Product

Group-III (Placebo)

Eligibility Criteria

• Age: 18 Years - 65 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

• Aurobindo Pharma Ltd: lead

Study Sites (1)

Maharashtra Medical Foundation Joshi Hospital

Pune, Maharashtra, 411004, India

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

Results Point of Contact

• Title: Dr. Joseph Marialouis
• Organization: Aurobindo Pharma

jmarialouis@aurobindousa.com

9196150585

Study Officials

• Joseph Marialouis

  Aurobindo Pharma USA Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 5, 2019
• First Posted: August 9, 2019
• Study Start: March 12, 2019
• Primary Completion: August 29, 2019
• Study Completion: December 20, 2019
• Last Updated: November 13, 2020
• Results First Posted: November 13, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)