Phase 3
Completed N=353
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)
Source: ClinicalTrials.gov NCT05755906 ↗Enrolled (actual)
353
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0 to 3 Hours (AUC0-3) at Week 12 — 0.309; 0.109 Liter — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0 to 3 Hours (AUC0-3) at Week 12 |
0.309; 0.109 | <0.0001 sig |
| SECONDARY Change From Baseline in Morning Pre-dose Trough FEV1 at Week 12 |
0.143; 0.060 | 0.0096 sig |
| SECONDARY Onset of Action on Day 1: Absolute Change in FEV1 at 5 Minutes on Day 1 |
0.179; 0.026 | <0.0001 sig |
| SECONDARY Change From Baseline in the Mean Number of Puffs of Rescue Medication Use (Puffs/Day) Over 12 Weeks |
-0.589; -0.309 | 0.0058 sig |
| SECONDARY Percentage of Responders in ACQ-7 (≥ 0.5 Decrease Equals Response) at Week 12 |
74.3; 61.9 | 0.0101 sig |
| SECONDARY Percentage of Responders in ACQ-5 (≥ 0.5 Decrease Equals Response) at Week 12 |
77.1; 62.5 | 0.0025 sig |
| SECONDARY Percentage of Responders in the Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s) +12) (≥ 0.5 Increase Equals Response) at Week 12 |
61.6; 47.5 | 0.0084 sig |
| SECONDARY Rate of Severe Asthma Exacerbation (Pooled LITHOS and VATHOS Data) During the Treatment Period (up to 24 Weeks) |
0.35; 0.42 | 0.3610 |
| SECONDARY Rate of Severe Asthma Exacerbation During the Treatment Period (up to 12 Weeks) |
0.25; 0.52 | 0.0419 sig |
Eligibility Criteria
Inclusion Criteria
- 12 to 80 years of age, male and female, BMI 10 pack-years history, or former smokers who stopped smoking < 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
- Planned hospitalization during the study.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
- Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions and requirements.
- For women only - currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.
Data sourced from ClinicalTrials.gov (NCT05755906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.