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Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg and Salmeterol 50 mcg inhalation powder/Respirent Pharmaceuticals (Test) or ADVAIR DISKUS® 100/50 mcg (Reference) or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test (T) | Experimental | Fluticasone propionate 100 mcg and Salmeterol 50 mcg inhalation powder/Respirent Pharmaceuticals |
|
| Reference (R) | Active Comparator | ADVAIR DISKUSĀ® 100/50 mcg inhalation powder pre-dispensed/GSK |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals | Drug | new generic product of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder twice daily inhalation throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the serial FEV1(L)-time curve calculated from time zero to 12 hours (AUC0-12h) on the first day of the treatment after adjustment for baseline (change from baseline) | 12 hours | |
| FEV1(L) measured in the morning prior to the dosing of inhaled medications on the last day of a 4-week treatment (trough FEV1) after adjustment for baseline (change from baseline) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of rescue medication used during the study period | 7 weeks | |
| Adverse events during the study period | 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Athanasios Konstantinidis, Ass.Professor | University of Ioannina School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BECRO Ltd. | Athens | Greece |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2021 | |
| Reset | Jul 8, 2021 |
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| ADVAIR DISKUSĀ® 100/50 mcg inhalation powder pre-dispensed/GSK | Drug | twice daily inhalation throughout the study |
|
|
| Placebo | Drug | twice daily inhalation throughout the study |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2021 | Jul 8, 2021 |
| 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 |
| D000068299 | Salmeterol Xinafoate |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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