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

ConditionsBronchiolitis Obliterans Syndrome Chronic Lung Allograft Dysfunction Lung Transplantation

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorSteven Hays, MD

About this trial

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 criteria

Qualifiers

Age > 18 years old

Recipient of a double pulmonary allograft at least 12 months before study entry

Subjects with clinically diagnosed CLAD-BOS phenotype (all 3 required)

BOS defined as screening FEV1 between 85-51% of the baseline as defined by the 2 highest FEV1 measures at least 3 weeks apart.

Disqualifiers

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Patients with re-transplantation or currently listed for re-transplantation

Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (CLAD - RAS phenotype, see Protocol Specific Definition), etc.

Trial design

Treatments tested in this trial

LAM-001
Placebo

Treatment groups

30 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Steven Hays, MD

Lead sponsor

University of California, San Francisco

Sponsor institution

OrphAI Therapeutics

Collaborator

Source ClinicalTrials.gov