Study of LAM-001 Inhaled Treatment to Slow Bronchiolitis Obliterans Syndrome After Lung Transplantation Phase 2 Randomized, Placebo-Controlled Trial Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome BOS, a form of chronic rejection following lung transplantation. This phase 2 trial aims to determine if inhaled LAM-001 can slow the progression of BOS, a serious condition that limits long-term survival after lung transplant. BOS currently has no effective treatment and is characterized by a steady decline in lung function despite available therapies. LAM-001 is designed to deliver sirolimus directly to the lungs, potentially reducing side effects seen with oral treatment. Participants in this randomized, placebo-controlled study will inhale either LAM-001 or a placebo daily for 48 weeks using a dry powder inhaler. The study includes 10 visits over this period, a mix of in-person and telehealth appointments. During the trial, participants will continue their standard immunosuppression therapy. Researchers will monitor lung function, including weekly home spirometry, and perform bronchoscopy, lab tests, and physical exams to assess safety and treatment effects. Throughout the study, participants will undergo regular assessments such as pulmonary function tests and bronchoscopy when needed. Lung function changes will be closely tracked, focusing on forced expiratory volume FEV1 to evaluate treatment impact. Safety will also be monitored continuously. The total participation time is 48 weeks, with researchers comparing outcomes between those receiving LAM-001 and placebo to determine the drugs tolerability and effectiveness in slowing BOS progression.

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