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Completed Phase 3 Interventional Results available

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)

ClinicalTrials.gov ID: NCT05755906

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.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 2:26 PM EDT

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05755906
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
374 participants

Conditions and interventions

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 27, 2023 (Actual)
Primary completion
Nov 19, 2024 (Actual)
Completion
Nov 19, 2024 (Actual)
Last update posted
Jan 28, 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 28, 2026 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05755906 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →