BE Study Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Asthma Patient
Study Details
Study Description
Brief Summary
The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Aerosol, 2 actuations orally inhaled twice daily |
Drug: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg
Inhalation aerosol, 2 actuations orally inhaled twice daily
Other Names:
|
| Active Comparator: Symbicort® Inhalation Aerosol, 2 actuations orally inhaled twice daily |
Drug: Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol
Inhalation aerosol, 2 actuations orally inhaled twice daily
Other Names:
|
| Placebo Comparator: Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Aerosol, 2 actuations orally inhaled twice daily |
Drug: Placebo
Inhalation aerosol, 2 actuations orally inhaled twice daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Area under the serial Force Expiration volume1 [From time 0 to 12 hours]
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment
- Change in FEV1 from baseline [6 weeks treatment]
FEV1 measured in the morning prior to the dosing of inhaled medication on the last day of the 6 weeks treatment
Secondary Outcome Measures
- Number and Severity of Adverse Events and Serious Adverse Events [6 weeks treatment]
Assessment of No. of AEs, its severity, and relatedness and SAE.,
- Assessment of vital signs: Pulse rate [6 weeks treatment]
Assessment of vital signs
- Number of participants with suspected oral infection performed with an oropharyngeal examination [6 weeks treatment]
Assessment of physical examination including oropharyngeal examination
- Assessment of vital signs: Systolic and diastolic Blood Pressures [6 weeks treatment]
Assessment of vital signs: Systolic and diastolic Blood Pressures
Eligibility Criteria
Criteria
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)
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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).
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Has been diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP 2007) at least 6 months prior to screening
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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
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Has history of any asthma-related hospitalizations within the past one year prior to screening visit (Visit 1) or during the run-in period
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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.
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Has current evidence of bronchopulmonary dysplasia or pulmonary fibrosis
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Has recent respiratory tract infection that is not resolved within 4 weeks of screening and is considered significant in the opinion of the investigator
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Patients who, in the opinion of the investigator, significantly abuse alcohol or drugs, will be excluded.
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Is taking any immunosuppressive medications within 4 weeks prior to the screening and during the study
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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.
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Women of childbearing potential who are lactating or pregnant at screening visit, as documented by a positive screening pregnancy test.
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Has previously been randomized in this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Velocity Clinical Research | Medford | Oregon | United States | 97504 |
Sponsors and Collaborators
- Cipla Ltd.
Investigators
- Principal Investigator: Orlando Rivero, MD, Global Research Solution
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRD/20