At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 374 enrolled
Drug / intervention
BFF MDI 160/9.6 μg BID (320/19.2μg/day) +1 moredrug
Likely dose
BFF MDI 160/9.6 μg BID (320/19.2μg/day)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Parallel Group, Multicenter 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)
In Brief
A Phase 3 clinical trial evaluating BFF MDI 160/9.6 μg BID (320/19.2μg/day) and BD MDI 160 μg BID (320 μg/day) for Asthma. Completed, enrolled 374 participants across 104 sites in 7 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesCanada, Czechia, Malaysia, Philippines, South Africa, South Korea, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
Enrollment StartFeb 2023
First PostedMar 2023
Primary CompletionNov 2024
TodayJul 2026
First PostedMar 6, 2023
Enrollment StartFeb 27, 2023
Primary CompletionNov 19, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.3 years ago
Interventions
BFF MDI 160/9.6 μg BID (320/19.2μg/day)drug
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), 160/9.6 μg BID (320/19.2μg/day)
BD MDI 160 μg BID (320 μg/day)drug
Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day)