LTI-03 for Idiopathic Pulmonary Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of a new inhaled medication, LTI-03, for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing problems. Participants will receive either a low dose, a higher dose, or a placebo (a substance with no active drug) to compare results. It suits those newly diagnosed with IPF who have not started other treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.
Do I need to stop my current medications to join the trial?
The trial requires that you stop using N-acetyl cysteine or other supplements 7 days before starting and throughout the treatment. If you're on antifibrotic therapy for IPF, you must stop it at least 2 months before the baseline bronchoscopy.
Is there any evidence suggesting that LTI-03 is likely to be safe for humans?
Research has shown that inhaled LTI-03 is generally safe and well-tolerated. In earlier studies, participants used LTI-03 for 14 days without major problems. It appears to help with lung scarring and protect lung cells, offering promise for people with idiopathic pulmonary fibrosis (IPF). No evidence of harm to cells was found, which is a positive sign. While these results are encouraging, it is important to remember that this is an early-stage trial, so more research is needed to confirm long-term safety.12345
Why do researchers think this study treatment might be promising?
Most treatments for idiopathic pulmonary fibrosis, like nintedanib and pirfenidone, work by slowing lung fibrosis. But LTI-03 works differently, targeting pathways that could potentially reduce inflammation and fibrosis more effectively. Researchers are excited about LTI-03 because it offers a novel approach, with two different dosing options (2.5 mg and 5 mg twice daily) that could provide flexibility in managing the condition. Additionally, its potential to act quickly over just 14 days makes it a promising alternative for more immediate relief compared to traditional therapies.
What evidence suggests that LTI-03 might be an effective treatment for IPF?
Research has shown that LTI-03 could be a promising treatment for idiopathic pulmonary fibrosis (IPF). In lab studies, LTI-03 reduced lung scarring and protected lung cells, suggesting it might slow the lung damage caused by IPF. It also prevented the buildup of excess fibrous tissue. Additionally, LTI-03 lowered harmful proteins and pathways linked to lung scarring. Studies in which participants inhaled LTI-03 showed it is generally well-tolerated and may positively affect lung health. Overall, these findings support LTI-03 as a potential new therapy for IPF.12467
Who Is on the Research Team?
Steven A. Shoemkaer, MD
Principal Investigator
Lung Therapeutics
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LTI-03 or placebo by inhalation for 14 days using a dry-powder inhaler
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LTI-03
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rein Therapeutics
Lead Sponsor
Lung Therapeutics, Inc
Lead Sponsor