Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of improvement in FEV1 measured before and after 4 weeks of treatment in adult patients with chronic stable asthma.

Official Title
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Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate Efficacy and Safety of Beclomethasone Dipropionate Metered Dose Inhaler (Inhalation Aerosol) (0.04mg/ INH) in Male and/ or Female Subjects With Asthma

Conditions
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Bronchial Asthma

Intervention / Treatment
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* Drug: Test Product
* Drug: Reference Product
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group-I (Test)<br>One inhalation of Beclomethasone dipropionate HFA, 0.04 mg/ INH (Test) twice daily. | Drug: Test Product<br>* Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg<br>* Other names: Test;|
| Active Comparator: Group-II (Reference)<br>One inhalation of QVAR® 40 mcg (Beclomethasone dipropionate HFA), Inhalation Aerosol twice daily. | Drug: Reference Product<br>* Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg<br>* Other names: QVAR;|
| Placebo Comparator: Group-III (Placebo)<br>One inhalation of Placebo Inhalation Aerosol twice daily. | Drug: Placebo<br>* Placebo Product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |