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A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS)

NCT05755906 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2026-01-28

Study results available
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Summary

This is a 12-week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler relative to budesonide metered dose inhaler in adults and adolescents with inadequately controlled asthma.

Conditions

Interventions

DRUG

BFF MDI 160/9.6 μg BID (320/19.2μg/day)

Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg BID (320/19.2μg/day)

DRUG

BD MDI 160 μg BID (320 μg/day)

Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day)

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
2023-02-27
Primary Completion
2024-11-19
Completion
2024-11-19
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • Malaysia
  • Philippines
  • South Africa
  • South Korea

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 NCT05755906 on ClinicalTrials.gov