BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma

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 FEV1 measures at different timepoints in adult patient with Asthma.

Official Title
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Multicenter Randomized Parallel-Group 6-Week Treatment Clinical Study to Assess BE of Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Comparison With Reference Product, Symbicort® in Adult Asthma Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg
* Drug: Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients who are 18-70 years of age Has moderate-to-severe asthma with a pre-bronchodilator FEV1 of ≥45% and <80% of the predicted normal value for the patient after withholding bronchodilators Has ≥15% and ≥0.20 L reversibility of FEV1 within 30 minutes following administration of 360 μg of albuterol (pMDI) Is stable on current chronic asthma treatment (documented asthma diagnosis and/or prescription for asthma medications) for at least 4 weeks prior to screening visit (Visit 1). Has been diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP 2007) at least 6 months prior to screening Adult male or female patients of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control Exclusion Criteria: Has history of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s), within past 1 year or during run-in period Has history of any asthma-related hospitalizations within the past one year prior to screening visit (Visit 1) or during the run-in period Has history of any pulmonary disorder other than asthma, including but not limited to: diagnosis of chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, bronchiectasis, chronic bronchitis, pulmonary hypertension, active pulmonary tuberculosis, or pulmonary carcinoma. Has current evidence of bronchopulmonary dysplasia or pulmonary fibrosis Has recent respiratory tract infection that is not resolved within 4 weeks of screening and is considered significant in the opinion of the investigator Patients who, in the opinion of the investigator, significantly abuse alcohol or drugs, will be excluded. Is taking any immunosuppressive medications within 4 weeks prior to the screening and during the study Use of systemic or oral corticosteroids within 2 months or intramuscular depot corticosteroid treatment 90 days prior to the screening or during the run-in period for any reason other than asthma. Women of childbearing potential who are lactating or pregnant at screening visit, as documented by a positive screening pregnancy test. Has previously been randomized in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg<br>Inhalation Aerosol, 2 actuations orally inhaled twice daily | Drug: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg<br>* Inhalation aerosol, 2 actuations orally inhaled twice daily<br>* Other names: Test product;|
| Active Comparator: Symbicort®<br>Inhalation Aerosol, 2 actuations orally inhaled twice daily | Drug: Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol<br>* Inhalation aerosol, 2 actuations orally inhaled twice daily<br>* Other names: RLD;|
| Placebo Comparator: Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg<br>Inhalation Aerosol, 2 actuations orally inhaled twice daily | Drug: Placebo<br>* Inhalation aerosol, 2 actuations orally inhaled twice daily<br>* Other names: Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serial Force Expiration volume1 | Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment | From time 0 to 12 hours | 
| Change in FEV1 from baseline | FEV1 measured in the morning prior to the dosing of inhaled medication on the last day of the 6 weeks treatment | 6 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Severity of Adverse Events and Serious Adverse Events | Assessment of No. of AEs, its severity, and relatedness and SAE., | 6 weeks treatment | 
| Assessment of vital signs: Pulse rate | Assessment of vital signs | 6 weeks treatment | 
| Number of participants with suspected oral infection performed with an oropharyngeal examination | Assessment of physical examination including oropharyngeal examination | 6 weeks treatment | 
| Assessment of vital signs: Systolic and diastolic Blood Pressures | Assessment of vital signs: Systolic and diastolic Blood Pressures | 6 weeks treatment |