RecruitingPhase 2NCT06018766

LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.

A Randomized, Placebo-controlled Phase 2 Study to Demonstrate the Safety and Efficacy of the Addition of LAM-001 to Standard Immunosuppression Therapy for Chronic Lung Allograft Dysfunction (BOS).


Sponsor

Steven Hays, MD

Enrollment

30 participants

Start Date

Aug 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn about the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, after lung transplantation. The main questions it aims to answer are: * Is LAM-001 safe in these patients? * Is LAM-001 effective in slowing BOS progression? Participants will: * Be randomly assigned to inhale either LAM-001 or placebo (a look-alike substance that contains no active drug) daily for 48 weeks * Attend 10 study visits (mixture of in-person and telehealth) over the 48 week period * Undergo pulmonary function testing, bronchoscopy, lab testing, and physical examination * Submit weekly home spirometry monitoring Researchers will compare participants assigned to LAM-001 versus placebo to see if LAM-001 is safely tolerated and to assess the effectiveness of LAM-001 on slowing BOS progression.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called LAM-001 and a drug called Placebo for people with bronchiolitis obliterans syndrome, chronic lung allograft dysfunction, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLAM-001

LAM-001 administered via dry powder inhaler

DRUGPlacebo

Placebo administered via dry powder inhaler


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT06018766


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