A randomized, multicenter, multiple-dose, double-blind, placebo-controlled, parallel-group design, clinical endpoint bioequivalence study to evaluate the therapeutic equivalence and safety of fluticasone furoate and vilanterol inhalation powder 100 mcg/25 mcg (Sandoz) and BREO® ELLIPTA® (fluticasone furoate and vilanterol inhalation powder) 100 mcg/25 mcg (GlaxoSmithKline) in adult participants with asthma

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521565-27-00

Acronym

SAN-1138

Enrollment

120

Registered

2025-09-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

FEV1 AUC0-24h on the first day of the treatment, FEV1 measured in the morning prior to the dosing of inhaled medications on the last day of the 4-week treatment period. Note: The primary endpoints will be baseline-adjusted (change from baseline).

Detailed description

Adverse events (including TEAEs, SAEs, and/or AEs leading to study medication/study discontinuation), vital signs, and physical examination findings.

Interventions

DRUGSalbutamol Aldo-Unión 100 microgramos/dosis suspensión para inhalación en envase a presión

DRUGInhalation powder with lactose monohydrate and magnesium stearate

DRUGBREO ELLIPTA

DRUGFluticasone furoate and Vilanterol inhalation powder 100 mcg/25 mcg

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
FEV1 AUC0-24h on the first day of the treatment, FEV1 measured in the morning prior to the dosing of inhaled medications on the last day of the 4-week treatment period. Note: The primary endpoints will be baseline-adjusted (change from baseline).	—

Secondary

Measure	Time frame
Adverse events (including TEAEs, SAEs, and/or AEs leading to study medication/study discontinuation), vital signs, and physical examination findings.	—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026