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)
Public ClinicalTrials.gov record NCT05755906. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Study identification
- NCT ID
- NCT05755906
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- AstraZeneca
- Industry
- Enrollment
- 374 participants
Conditions and interventions
Conditions
Interventions
- BFF MDI 160/9.6 μg BID (320/19.2μg/day) Drug
- BD MDI 160 μg BID (320 μg/day) Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 26, 2023
- Primary completion
- Nov 18, 2024
- Completion
- Nov 18, 2024
- Last update posted
- Jan 27, 2026
2023 – 2024
United States locations
- U.S. sites
- 63
- U.S. states
- 22
- U.S. cities
- 57
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Chandler | Arizona | 85224 | — |
| Research Site | Mesa | Arizona | 85213 | — |
| Research Site | Tucson | Arizona | 85745 | — |
| Research Site | Bakersfield | California | 93301 | — |
| Research Site | Encinitas | California | 92024 | — |
| Research Site | Fresno | California | 93720 | — |
| Research Site | Huntington Beach | California | 92647 | — |
| Research Site | Los Angeles | California | 90017 | — |
| Research Site | Los Angeles | California | 90025 | — |
| Research Site | Los Angeles | California | 90048 | — |
| Research Site | Newport Beach | California | 92663 | — |
| Research Site | Northridge | California | 91324 | — |
| Research Site | Sacramento | California | 95823 | — |
| Research Site | San Diego | California | 92123 | — |
| Research Site | San Jose | California | 95117 | — |
| Research Site | Ventura | California | 93003 | — |
| Research Site | Walnut Creek | California | 94598 | — |
| Research Site | Cutler Bay | Florida | 33189 | — |
| Research Site | DeBary | Florida | 32713 | — |
| Research Site | DeLand | Florida | 32720 | — |
| Research Site | Miami | Florida | 33155 | — |
| Research Site | Miami | Florida | 33173 | — |
| Research Site | Miami | Florida | 33175 | — |
| Research Site | Miami | Florida | 33180 | — |
| Research Site | Plantation | Florida | 33324 | — |
| Research Site | Tampa | Florida | 33607 | — |
| Research Site | Atlanta | Georgia | 30361 | — |
| Research Site | South Bend | Indiana | 46617 | — |
| Research Site | Lexington | Kentucky | 40509 | — |
| Research Site | Annapolis | Maryland | 21401 | — |
| Research Site | White Marsh | Maryland | 21162 | — |
| Research Site | North Dartmouth | Massachusetts | 02747 | — |
| Research Site | Farmington Hills | Michigan | 48336 | — |
| Research Site | Rolla | Missouri | 65401 | — |
| Research Site | St Louis | Missouri | 63141 | — |
| Research Site | Kalispell | Montana | 59901 | — |
| Research Site | Missoula | Montana | 59808 | — |
| Research Site | Bellevue | Nebraska | 68123 | — |
| Research Site | Henderson | Nevada | 89052 | — |
| Research Site | Las Vegas | Nevada | 89102 | — |
| Research Site | North Las Vegas | Nevada | 89030 | — |
| Research Site | Portsmouth | New Hampshire | 03801 | — |
| Research Site | New Windsor | New York | 12553 | — |
| Research Site | Schenectady | New York | 12308 | — |
| Research Site | Fayetteville | North Carolina | 28314 | — |
| Research Site | Raleigh | North Carolina | 27607 | — |
| Research Site | Columbus | Ohio | 43215 | — |
| Research Site | Edmond | Oklahoma | 73034 | — |
| Research Site | Oklahoma City | Oklahoma | 73120 | — |
| Research Site | Hatboro | Pennsylvania | 19040 | — |
| Research Site | Pittsburgh | Pennsylvania | 15236 | — |
| Research Site | Austin | Texas | 78704 | — |
| Research Site | Beaumont | Texas | 77701 | — |
| Research Site | Boerne | Texas | 78006 | — |
| Research Site | El Paso | Texas | 79912 | — |
| Research Site | Forney | Texas | 75126 | — |
| Research Site | San Antonio | Texas | 78229 | — |
| Research Site | San Antonio | Texas | 78258 | — |
| Research Site | Victoria | Texas | 77901 | — |
| Research Site | Waco | Texas | 76712 | — |
| Research Site | American Fork | Utah | 84003 | — |
| Research Site | Bountiful | Utah | 84010 | — |
| Research Site | Milwaukee | Wisconsin | 53228 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05755906, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 27, 2026 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05755906 live on ClinicalTrials.gov.