A Randomized, Double-Blind, Parallel Group, Multicenter 24 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler and Open-Label Symbicort® Turbuhaler® in Participants with Inadequately Controlled Asthma (VATHOS)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513568-24-00

Acronym

D5982C00006

Enrollment

160

Registered

2024-06-12

Start date

2022-03-23

Completion date

2025-02-12

Last updated

2025-02-20

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

Conditions

Inadequately Controlled Asthma

Brief summary

1. Change from baseline in morning pre-dose trough FEV1 over 24 weeks.

Detailed description

1.Change from baseline in FEV1 AUC0-3 over 24 Weeks., 2.Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks., 3.Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) over 24 Weeks., 4.Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) over 24 Weeks., 5.Percentage of responders in the AQLQ(s)+12 (≥ 0.5 increase equals response) over 24 Weeks., 6.Percentage of responders in AQLQ(s)+12 (≥ 0.5 increase equals response) over 12 to 24 weeks., 7.Onset of action on Day 1: Absolute change in FEV1 at 5 minutes post dose on Day 1.

Interventions

DRUGSymbicort

DRUG160 mikrogram/4

DRUG5 mikrogram/puff inhalationsspray

DRUGsuspension

DRUGBFF (PT009)

DRUGBD ( PT008)

DRUGSALBUTAMOL

DRUGPlacebo MDI and empty TBH devices (only for training purposes)

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Change from baseline in morning pre-dose trough FEV1 over 24 weeks.	—

Secondary

Measure	Time frame
1.Change from baseline in FEV1 AUC0-3 over 24 Weeks., 2.Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks., 3.Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) over 24 Weeks., 4.Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) over 24 Weeks., 5.Percentage of responders in the AQLQ(s)+12 (≥ 0.5 increase equals response) over 24 Weeks., 6.Percentage of responders in AQLQ(s)+12 (≥ 0.5 increase equals response) over 12 to 24 weeks., 7.Onset of action on Day 1: Absolute change in FEV1 at 5 minutes post dose on Day 1.	—

Measure

Time frame

—

Countries

Germany, Italy, Spain

Outcome results

None listed

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