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Corticosteroid
Budesonide + Formoterol for Asthma (LITHOS Trial)
Phase 3
Recruiting
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
Timeline
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 belowSelect...
My lung function tests show less than 90% of the expected value before treatment.
Select...
My lung function improves significantly after taking albuterol.
LITHOS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 12
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 moreLITHOS 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
4,268 Previous Clinical Trials
288,612,138 Total Patients Enrolled
328 Trials studying Asthma
639,294 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use a nebulizer for my asthma treatment.I received a COVID-19 vaccine less than a week ago.I can't stop taking certain medications that aren't allowed in the study.My lung function tests show less than 90% of the expected value before treatment.My lung function improves significantly after using albuterol.I am not pregnant, breastfeeding, planning to become pregnant, or I am using effective birth control.My cancer cannot be removed by surgery and has not been fully gone for 5 years.I will be hospitalized during the study.You need to use the electronic diary at least 70% of the time during screening and show that you used the study inhaler regularly.I have been on a stable asthma medication regimen for at least 8 weeks.I am between 12 and 80 years old, my BMI is under 40, and if I can have children, I use effective birth control.I am between 12 and 80 years old, my BMI is under 40, and if I can have children, I use effective birth control.Your asthma must be stable during the trial's initial period, as determined by the doctor based on specific guidelines.I am willing to change my asthma treatment if needed.I am a current smoker, or I used to smoke more than 10 pack-years, or I quit smoking less than 6 months ago.I have been diagnosed with asthma for at least 6 months and can provide health records.I have been on a stable asthma medication regimen for at least 8 weeks.I have had severe asthma attacks that required breathing support.I have a serious health condition affecting my heart, liver, kidneys, blood, nerves, hormones, stomach, or lungs.I was hospitalized for asthma within the last 8 weeks.I have been diagnosed with asthma for at least 6 months.My lung function improves significantly after taking albuterol.I haven't used steroids or extra inhalers for asthma or lung infections in the last 8 weeks.Your lung function test results at each visit can't change by 20% or more compared to the previous visit.Show that you can use an inhaler correctly.
Research Study Groups:
This trial has the following groups:- Group 1: BFF MDI 160/9.6 μg BID (320/19.2μg/day)
- Group 2: BD MDI 160 μg BID (320 μg/day)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
California
Texas
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
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
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