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Budesonide + Formoterol for Asthma (LITHOS Trial)
LITHOS Trial Summary
This trial tests if two inhalers are better than one to control asthma in adults & teens.
LITHOS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowLITHOS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.LITHOS Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: BFF MDI 160/9.6 μg BID (320/19.2μg/day)
- Group 2: BD MDI 160 μg BID (320 μg/day)
- 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.
- 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
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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