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

Part of paid clinical trials in San Francisco, California.

Sponsor
Steven Hays, MD
Study ID
NCT06018766
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bronchiolitis Obliterans Syndrome
  • Chronic Lung Allograft Dysfunction
  • Lung Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LAM-001 — DRUG
    LAM-001 administered via dry powder inhaler
  • Placebo — DRUG
    Placebo administered via dry powder inhaler

Study Details

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.

Key Dates

Start date
Aug 17, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LAM-001
  • Placebo Comparator: Placebo

Primary Outcome Measure

% change in FEV1 from baseline [ Time Frame: 48 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Steven Hays, MD
[email protected]
415-353-4141
Steven Hays, MD (PRINCIPAL_INVESTIGATOR)
Julia Maheshwari, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, San Francisco· San Francisco, CA

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