What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include nintedanib and pirfenidone, both of which aim to slow disease progression by reducing lung fibrosis. Nintedanib is associated with side effects such as diarrhea, nausea, and liver enzyme elevation, which may require dose adjustments. Pirfenidone commonly causes nausea, rash, and photosensitivity, and it may also lead to liver enzyme abnormalities. Both medications have shown efficacy in slowing the decline in lung function, but they do not cure the disease.

What prior FDA approvals exist?

The FDA has approved two primary drugs for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib is a tyrosine kinase inhibitor that targets multiple pathways involved in fibrosis, thereby slowing the decline in lung function. Pirfenidone is an antifibrotic agent that reduces fibroblast proliferation and collagen synthesis, also helping to slow disease progression. Both drugs have demonstrated efficacy in reducing the rate of lung function decline and the frequency of acute exacerbations in IPF patients.

What other types of research exist?

Promising novel alternatives to LTI-03 for IPF patients include: 1) Nintedanib, which slows disease progression and reduces acute exacerbations. 2) Pirfenidone, which also slows disease progression and has shown benefits in various stages of IPF. 3) Lebrikizumab, an IL-13 monoclonal antibody, currently in phase 2 trials. 4) Pamrevlumab, an anti-connective tissue growth factor therapy, which has shown positive results in phase 2 trials. These alternatives have demonstrated potential in reducing lung inflammation or fibrosis in IPF patients.

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LTI-03 for Idiopathic Pulmonary Fibrosis

Phase 1

Waitlist Available

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)

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days (dosing x 14 days; follow up x 7 days) for reporting.

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

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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.