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This is a randomized, assessor-blind, placebo controlled, multicenter, clinical endpoint bioequivalence study to compare the efficacy and safety of generic fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd) to Flovent HFA (fluticasone propionate inhalation aerosol) 44 mcg (GSK group of companies) in treatment of patients with bronchial asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd.) | Experimental |
| |
| FLOVENT HFA | Active Comparator |
| |
| Placebo of Fluticasone propionate inhalation aerosol 44 mcg | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate Inhalation Aerosol 44 mcg | Drug | Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning & evening approximately. 12 h apart, Mode of Administration: Oral inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| - Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period | From Baseline to last day of 4-week treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ameet Daftary, MD | Contact | 2016848000 | mahesh.deshpande@glenmarkpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Ameet Daftary | Glenmark Pharmaceuticals Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site 9 | Recruiting | Ahmedabad | Gujarat | 411057 | India | |
| Investigational Site 2 |
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| FLOVENT HFA 44 mcg | Drug | Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning & evening approximately. 12 h apart, Mode of Administration: Oral inhalation |
|
| Matching Placebo inhaler | Drug | Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning & evening approximately. 12 h apart, Mode of Administration: Oral inhalation |
|
| Recruiting |
| Aurangabad |
| Maharashtra |
| 431002 |
| India |
| Investigational Site 6 | Recruiting | Nagpur | Maharashtra | 440009 | India |
| Investigational Site 16 | Active, not recruiting | Nashik | Maharashtra | 422002 | India |
| Investigational Site 11 | Active, not recruiting | Nashik | Maharashtra | 422005 | India |
| Investigational Site 10 | Active, not recruiting | Nashik | Maharashtra | 422007 | India |
| Investigational Site 3 | Recruiting | Pune | Maharashtra | 411047 | India |
| Investigational Site 1 | Recruiting | Pune | Maharashtra | India |
| Investigational Site 4 | Recruiting | Jaipur | Rajasthan | 302039 | India |
| Investigational Site 13 | Recruiting | Hyderabad | Telangana | 500038 | India |
| Investigational Site 5 | Recruiting | Hyderabad | Telangana | 500038 | India |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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