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LTI-03 for Idiopathic Pulmonary Fibrosis
Phase 1
Recruiting
Research Sponsored by Lung Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days (dosing x 14 days; follow up x 7 days)
Awards & highlights
Study Summary
This trial tests the safety & effectiveness of a new inhaler for people with a lung disease called IPF.
Who is the study for?
This trial is for adults over 40 with newly diagnosed Idiopathic Pulmonary Fibrosis (IPF), confirmed by specific tests, who haven't been in other drug studies recently. They must have certain lung function levels and can't be severely ill or unable to use the inhaler. Women of childbearing age and men with partners must agree to contraception.Check my eligibility
What is being tested?
The study is testing LTI-03, an inhaled medication for IPF patients who haven't had treatment before. Participants will either receive LTI-03 or a placebo to check how safe it is and how well they tolerate it.See study design
What are the potential side effects?
While the side effects of LTI-03 are being studied, common issues may include irritation at the inhalation site, coughing, shortness of breath, or potential allergic reactions due to new medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 days (dosing x 14 days; follow up x 7 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days (dosing x 14 days; follow up x 7 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-emergent adverse events (TEAEs)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 5 mg LTI-03 BIDExperimental Treatment1 Intervention
5 mg LTI-03 BID x 14 days
Group II: 2.5 mg LTI-03 BIDExperimental Treatment1 Intervention
2.5 mg LTI-03 BID x 14 days
Group III: PlaceboPlacebo Group1 Intervention
Matching placebo BID x 14 days
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Who is running the clinical trial?
Lung Therapeutics, IncLead Sponsor
2 Previous Clinical Trials
115 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
71 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Steven A. Shoemkaer, MDStudy DirectorLung Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are unable to use the inhaler properly.You have a history of severe liver problems, as indicated by specific blood test results.You have a serious lung condition that affects your breathing.If you are a woman who could become pregnant, and your urine test shows that you are pregnant, you cannot participate.Your lung function test shows that your lungs can take in a certain amount of air, but not too much.You are 40 years old or older.You have taken N-acetyl cysteine or other supplements within the past 7 days before starting the treatment.You have a lung disease that is not IPF.You have been diagnosed with IPF within the past 3 years, confirmed by a special type of chest scan or a lung biopsy following specific medical guidelines.Your lung function is at least 40% of what is expected for someone your age and size.You had a fever within the week before starting the treatment.You have a history of serious kidney problems with a specific measure called eGFR less than 30 mL/min.You had a serious lung problem in the 6 months before the screening.Your lung function test shows that you can exhale a good amount of air in the first second.You have been diagnosed with asthma.You have taken a specific treatment for IPF within 2 months before the start of the study.
Research Study Groups:
This trial has the following groups:- Group 1: 5 mg LTI-03 BID
- Group 2: 2.5 mg LTI-03 BID
- Group 3: Placebo
Awards:
This trial has 0 awards, including: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.
Has 2.5 mg LTI-03 administered twice daily received regulatory clearance?
"The safety of 2.5 mg LTI-03 BID was rated a 1 due to the preliminary nature of Phase 1 trials, which have only limited data supporting its efficacy and potential harms."
Answered by AI
How many participants can this clinical trial accommodate?
"Confirmed. According to clinicaltrials.gov, this medicinal study was initialled posted on July 6th 2023 and the most current update was recorded on August 29th 2023. It is actively recruiting 24 individuals between 8 different medical sites."
Answered by AI
Are there vacancies available for participants in this experiment?
"According to clinicaltrials.gov, recruitment for this trial is ongoing and began on July 6th 2023 with the most recent edit occurring on August 29th of the same year."
Answered by AI
What is the geographical scope of this trial's implementation?
"The 8 sites participating in this medical trial include the University of Southern California, Cedars Sinai Medical Center, and Agaplesion Evangelisches Krankenhaus Mittelhessen. Additionally, there are five other clinical research centres involved."
Answered by AI
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