A Phase II, Randomized, Double-blind, 3-Period Cross-over, Dose‑ranging Study to Assess the Efficacy and Safety of Glycopyrronium (GP) versus Placebo in Participants of 4 to Less than 12 Years of Age with Asthma Receiving Background Budesonide and Formoterol Fumarate (BFF) (FAROS)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524914-26-00

Enrollment

Registered

2026-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-01

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

Conditions

Asthma

Brief summary

Change from baseline in FEV1 at 1 hour post-dose measured at EoT (at 3 weeks).

Detailed description

Change from baseline in morning pre-dose trough FEV1 at EoT (at 3 weeks).

Interventions

DRUGBFF (PT009)

DRUGPlacebo MDI

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline in FEV1 at 1 hour post-dose measured at EoT (at 3 weeks).	—

Secondary

Measure	Time frame
Change from baseline in morning pre-dose trough FEV1 at EoT (at 3 weeks).	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 2, 2026