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NCT05755906 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 374
- Enrollment target
NCT05755906: Completed Phase 3 study, sponsored by AstraZeneca.
NCT05755906 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 374 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05755906, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 374 participants
- Enrollment target
Study 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.
Primary Outcome
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12. FEV1 AUC0-3 is calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time to report the result in liters. Treatment policy is implemented to handle all intercurrent events with the exception of initiation of new asthma therapy or administration of prohibited medications thought to impact efficacy in conjunction with premature discontinuat
Interventions
- DRUG BFF MDI 160/9.6 μg BID (320/19.2μg/day)
- DRUG BD MDI 160 μg BID (320 μg/day)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 374 participants |
| Start Date | 2023-02-27 |
| Est. Completion | 2024-11-19 |
| Phase | Phase 3 |
What the finished NCT05755906 record still lists
NCT05755906 is an interventional study that assigns participants to a tested intervention. The registered 374 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which BFF MDI 160/9.6 μg BID (320/19.2μg/day) is the first listed.
NCT05755906 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05755906 about?
NCT05755906 is a clinical study titled "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)". 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.
What is the current status of trial NCT05755906?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 374 participants. The study started on 2023-02-27. Estimated completion is 2024-11-19.
What interventions are being tested in trial NCT05755906?
The interventions under investigation include: BFF MDI 160/9.6 μg BID (320/19.2μg/day) (DRUG), BD MDI 160 μg BID (320 μg/day) (DRUG).
Who is sponsoring clinical trial NCT05755906?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05755906's enrollment target sits among peer trials
374 991st of 2000 higher than 1,010 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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