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LAM-001 for Bronchiolitis Obliterans Syndrome (INSPO-BOS Trial)

Phase 2
Recruiting
Research Sponsored by Steven Hays, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years old
Subjects with clinically diagnosed CLAD-BOS phenotype
Must not have
Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome
Active acute bacterial, viral, or fungal infection that has not successfully resolved in at least 4 weeks prior to the Screening Visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed pre-inhalation at in-person study visits over 48 weeks and post-inhalation at 3 months post randomization

Summary

This trial will investigate the safety and effectiveness of inhaled sirolimus to slow bronchiolitis obliterans syndrome (BOS) progression in lung transplant recipients. Participants will be randomly assigned to inhale sirolimus or placebo for 48 weeks and attend 10 visits.

Who is the study for?
This trial is for adults over 18 who've had a double lung transplant at least a year ago and are now facing chronic rejection called bronchiolitis obliterans syndrome (BOS). They should have specific lung function levels, be on standard immunosuppression, and not be taking certain drugs. Participants must use effective birth control if they can have children and cannot donate sperm or eggs during the study.
What is being tested?
The trial tests LAM-001's safety and effectiveness against BOS in lung transplant recipients. Patients will either inhale LAM-001 or a placebo daily for 48 weeks while undergoing regular health checks including lung function tests, with some visits possibly via telehealth.
What are the potential side effects?
While the side effects of LAM-001 aren't detailed here, typical inhalation therapy risks may include coughing, throat irritation, or allergic reactions. The study aims to ensure that LAM-001 is safe for patients with BOS.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I have been diagnosed with CLAD-BOS.
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I am currently on standard immunosuppression therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lung function loss is due to a confirmed cause like infection or rejection.
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I have had an infection that didn't clear up in the last 4 weeks.
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I have breathing tube narrowing that started after my BOS diagnosis and is still present.
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I have chronic kidney disease.
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I don't have a cancer history that needs major treatment soon.
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My blood pressure is not controlled by medication.
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My liver function tests are not more than 3 times the normal limit.
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I need extra oxygen or my oxygen levels are below 89% without it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed pre-inhalation at in-person study visits over 48 weeks and post-inhalation at 3 months post randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed pre-inhalation at in-person study visits over 48 weeks and post-inhalation at 3 months post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to Progression Free Survival (PFS), Level 1
Secondary study objectives
Change in FEV1
Change in forced expiratory volume in one second/forced vital capacity (FEV1/FVC)
Time to Progression Free Survival (PFS), Level 2
Other study objectives
% Reduced donor-derived cell-free DNA
Adverse events
Airway Hypersensitivity to Treatment
+7 more

Side effects data

From 2020 Phase 2 & 3 trial • 852 Patients • NCT01120028
49%
Infections and infestations
20%
Surgical and medical procedures
17%
Immune system disorders
14%
Gastrointestinal disorders
12%
Investigations
10%
Metabolism and nutrition disorders
9%
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
7%
Injury, poisoning and procedural complications
5%
Cardiac disorders
4%
Respiratory, thoracic and mediastinal disorders
4%
Renal and urinary disorders
4%
Nervous system disorders
3%
General disorders and administration site conditions
2%
Blood and lymphatic system disorders
2%
Musculoskeletal and connective tissue disorders
2%
Vascular disorders
2%
Hepatobiliary disorders
1%
Eye disorders
1%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2: Sirolimus
Period 1: Alemtuzumab/Tacrolimus
Period 1: Basiliximab/Tacrolimus
Period 2: Tacrolimus

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LAM-001Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Lactose capsule to be inhaled daily for 48 weeks via Plastiape RS01 dry powder inhaler Model 7.

Find a Location

Who is running the clinical trial?

AI Therapeutics, Inc.Industry Sponsor
6 Previous Clinical Trials
250 Total Patients Enrolled
Steven Hays, MDLead Sponsor
OrphAI TherapeuticsIndustry Sponsor
6 Previous Clinical Trials
250 Total Patients Enrolled
~13 spots leftby Dec 2025
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