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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
Summary
This trial will test the safety and tolerability of an inhaled medication called LTI-03 in people who have been diagnosed with idiopathic pulmonary fibrosis (IPF) and have not yet received any treatment. The medication is inhaled directly into the lungs to see if it can help with the symptoms of 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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Nintedanib and pirfenidone are the most common treatments for Idiopathic Pulmonary Fibrosis (IPF). Nintedanib is a tyrosine kinase inhibitor that targets multiple growth factor receptors involved in the fibrotic process, thereby slowing disease progression by inhibiting pathways that lead to fibrosis.
Pirfenidone, on the other hand, has antifibrotic and anti-inflammatory properties, reducing the production of fibrogenic mediators and collagen synthesis. These mechanisms are crucial for IPF patients as they help to slow the progression of lung fibrosis, improve lung function, and potentially reduce the frequency of acute exacerbations, thereby enhancing the quality of life and survival rates.
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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.
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