NCT04790838

Pooled Analysis FP_SX_250_50

Pooled Analysis of Individual Subjects' Data After Combining the Data From the Bioequivalence Studies Conducted for Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals (Test, T) vs ADVAIR DISKUS® 250/50 mcg Inhalation Powder/GSK (Reference, R)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 82 (actual)
• Sponsor: Respirent Pharmaceuticals Co Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A pooled analysis of three bioequivalence studies conducted for Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (Test, T) vs ADVAIR DISKUS® 250/50 mcg inhalation powder/GSK (Reference, R) were conduted.

Detailed description

Data from three Bioequivalence studies with study codes: BECRO/RESP/BREATH-BE250-PIVOTAL (BE250-PIVOTAL), BECRO/RESP/BREATH-BE250-PILOT (BE250-PILOT) and BECRO/RESP/BREATH-PK250 (PK250) were included. A pooled analysis of all three studies was conducted, including all eighty-two (82) subjects of the three studies. Then, a pooled analysis of the BE250-PIVOTAL and the respective Pilot study (BE250-PILOT) was also conducted since these two studies used products of the same batch, including forty-eight (48) subjects.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Test	2 inhalations of Test and Reference product in each study period
DRUG	Reference	2 inhalations of Test and Reference product in each study period

Timeline

• Start date: 2019-06-02
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2021-03-10
• Last updated: 2021-03-10

Locations

1 site across 1 country: Greece

Regulatory

• FDA-regulated drug study