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Budesonide + Formoterol for Asthma (LITHOS Trial)

Phase 3
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre-bronchodilator/pre-dose FEV1 < 90% predicted normal value at Visits 1, 2, and 3 and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization)
Reversibility to albuterol, defined as a post-albuterol increase in FEV1 of ≥ 12% and ≥ 200 mL for participants ≥ 18 years of age OR a post-albuterol increase in FEV1 of ≥ 12% for participants 12 to < 18 years of age
Screening 3 weeks
Treatment Varies
Follow Up at week 12
Awards & highlights

LITHOS Trial Summary

This trial tests if two inhalers are better than one to control asthma in adults & teens.

Who is the study for?
This trial is for adults and adolescents aged 12-80 with poorly controlled asthma, a BMI under 40, and who can use an inhaler correctly. Women of childbearing age must use effective birth control. Participants should have been on a stable inhaled corticosteroid (ICS) or ICS/LABA regimen for at least 8 weeks, have consistent lung function measurements, and not be current smokers or recent quitters.Check my eligibility
What is being tested?
The study compares the effectiveness of two asthma treatments over 12 weeks: Budesonide/Formoterol Fumarate Metered Dose Inhaler (BFF MDI) versus Budesonide Metered Dose Inhaler (BD MDI). It aims to determine if adding formoterol improves asthma control compared to budesonide alone.See study design
What are the potential side effects?
Potential side effects may include throat irritation, hoarseness, thrush in the mouth or throat, coughing, headaches, increased heart rate/palpitations, tremors/shakiness and possible worsening of asthma symptoms.

LITHOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My lung function tests show less than 90% of the expected value before treatment.
My lung function improves significantly after taking albuterol.

LITHOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12
Secondary outcome measures
Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 12 Weeks
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1
Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 12
+3 more

LITHOS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BFF MDI 160/9.6 μg BID (320/19.2μg/day)Experimental Treatment1 Intervention
Budesonide/ Formoterol Fumarate (BFF) metered-dose inhaler (MDI), BDI (320/19.2μg/day)
Group II: BD MDI 160 μg BID (320 μg/day)Active Control1 Intervention
Budesonide (BD) metered-dose inhaler (MDI), 160 μg BID (320 μg/day)

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Who is running the clinical trial?

AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,641 Total Patients Enrolled
328 Trials studying Asthma
639,294 Patients Enrolled for Asthma

Media Library

Budesonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05755906 — Phase 3
Asthma Research Study Groups: BFF MDI 160/9.6 μg BID (320/19.2μg/day), BD MDI 160 μg BID (320 μg/day)
Asthma Clinical Trial 2023: Budesonide Highlights & Side Effects. Trial Name: NCT05755906 — Phase 3
Budesonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05755906 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor allow participants aged 40 or above to join?

"The criteria for inclusion in this trial necessitates that enrollees are between the ages of 12 and 80. There are 128 trials specifically targeting minors, whereas 204 studies cater to those above the age of 65."

Answered by AI

Is my profile compatible with the requirements of this clinical trial?

"Eligible candidates for this medical trial must be between the ages of 12 and 80, suffer from asthma and are expected to number around 340 people."

Answered by AI

How many venues is this clinical experiment being conducted in?

"This trial is currently operational in 44 clinical locations, including Los Angeles, Newport Beach and San Diego. Patients should pick the closest site to their home so they can reduce travel commitments if they join this study."

Answered by AI

What potential risks come with utilizing the BFF MDI 160/9.6 μg BID (320/19.2μg/day) treatment protocol?

"There is a high degree of trust regarding the safety profile of BFF MDI 160/9.6 μg BID (320/19.2μg/day) given that it is currently in Phase 3 trials, which means there has been ample evidence to support its efficacy and security protocols have been rigorously tested throughout multiple rounds of testing."

Answered by AI

Are there any vacancies left for participants in this examination?

"This investigation, which was initially posted on February 24th 2023 and last modified the day prior, is not open to recruitment at this time. However, there are 330 other trials actively recruiting participants as of now."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?

Why did patients apply to this trial?

I have tried many treatments and still have not found one that I can lead a normal life.
PatientReceived 2+ prior treatments
~89 spots leftby Sep 2024