Phase 3
Completed N=581
A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)
Source: ClinicalTrials.gov NCT05202262 ↗Enrolled (actual)
581
Serious AEs
2.4%
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 24 — 0.276; 0.240; 0.067; 0.240 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 This can indicate results are unpublished — a known publication-bias signal.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 24 week study to evaluate the efficacy and safety of budesonide and formoterol fumarate 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 24 |
0.276; 0.240; 0.067; 0.240 | <0.0001 sig |
| SECONDARY Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 |
0.125; 0.099; 0.038; 0.131 | 0.0447 sig |
| SECONDARY Onset of Action on Day 1: Absolute Change in FEV1 at 5 Minutes on Day 1 |
0.236; 0.184; 0.041; 0.161 | <0.0001 sig |
| SECONDARY Change From Baseline in the Mean Number of Puffs of Rescue Medication Use (Puffs/Day) Over 24 Weeks |
-0.350; -0.481; -0.213; -0.443 | 0.0146 sig |
| SECONDARY Percentage of Responders in ACQ-7 (≥ 0.5 Decrease Equals Response) at Week 24 |
70.7; 68.4; 62.7; 71.4 | 0.2977 |
| SECONDARY Percentage of Responders in ACQ-5 (≥ 0.5 Decrease Equals Response) at Week 24 |
75.6; 71.6; 65.8; 68.8 | 0.2477 |
| 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 24 |
53.2; 57.7; 47.1; 50.3 | 0.0194 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 24 Weeks) |
0.26; 0.36; 0.35; 0.41 | 0.9473 |
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 (NCT05202262). 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.