A Phase 3 interventional study of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals and ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK in Asthma, sponsored by Respirent Pharmaceuticals Co Ltd.. Completed at 1 site in Greece. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by Respirent Pharmaceuticals Co Ltd. · Phase 3, Interventional, and Other
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 451 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Respirent Pharmaceuticals Co Ltd. is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Fluticasone propionate 100 mcg and Salmeterol 50 mcg inhalation powder/Respirent Pharmaceuticals
Drug: Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals
ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK
Drug: ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK
Drug: Placebo
new generic product of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder twice daily inhalation throughout the study
twice daily inhalation throughout the study
Also known as: ADVAIR DISKUS
twice daily inhalation throughout the study
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)
Time frame: 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)
Time frame: 4 weeks
Frequency of rescue medication used during the study period
Time frame: 7 weeks
Adverse events during the study period
Time frame: 7 weeks
Plan to share: No
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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Respirent Pharmaceuticals Co Ltd.