# 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** · PHASE3 · COMPLETED · sponsor: **AstraZeneca** · enrollment: 374 (actual)

## Conditions studied

- Asthma

## Interventions

- **DRUG:** BFF MDI 160/9.6 μg BID (320/19.2μg/day)
- **DRUG:** BD MDI 160 μg BID (320 μg/day)

## Key facts

- **NCT ID:** NCT05755906
- **Lead sponsor:** AstraZeneca
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2023-02-27
- **Primary completion:** 2024-11-19
- **Final completion:** 2024-11-19
- **Target enrollment:** 374 (ACTUAL)
- **Last updated:** 2026-01-28


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05755906

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05755906, "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)". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT05755906. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*