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A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)

NCT05202262 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2026-01-28

Study results available
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Summary

This is a 24 week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler in adults and adolescents with inadequately controlled asthma.

Conditions

Interventions

DRUG

BFF MDI 320/9.6 μg

Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 320/9.6 μg

DRUG

BFF MDI 160/9.6 μg

Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg

DRUG

BD MDI 320 μg

Budesonide MDI (BD MDI), 320 μg

DRUG

Open-label Symbicort TBH 320/9 μg

Open-label Symbicort Turbuhaler 320/9 μg

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-12
Primary Completion
2025-02-26
Completion
2025-02-26
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Japan
  • Spain
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05202262 on ClinicalTrials.gov