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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

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

Awards & highlights

INSPO-BOS Trial 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.Check my eligibility

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.See study design

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.

INSPO-BOS Trial 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.

INSPO-BOS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed pre-inhalation at in-person study visits over 48 weeks and post-inhalation at 3 months post randomization

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to Progression Free Survival (PFS), Level 1

Secondary outcome measures

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 outcome measures

% 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

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Injury, poisoning and procedural complications

Cardiac disorders

Respiratory, thoracic and mediastinal disorders

Renal and urinary disorders

Nervous system disorders

General disorders and administration site conditions

Blood and lymphatic system disorders

Musculoskeletal and connective tissue disorders

Vascular disorders

Hepatobiliary disorders

Eye disorders

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Period 2: Sirolimus

Period 1: Alemtuzumab/Tacrolimus

Period 1: Basiliximab/Tacrolimus

Period 2: Tacrolimus

INSPO-BOS 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AI Therapeutics, Inc.Industry Sponsor

6 Previous Clinical Trials

246 Total Patients Enrolled

Steven Hays, MDLead Sponsor

OrphAI TherapeuticsIndustry Sponsor

6 Previous Clinical Trials

246 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards should be taken into account when using Sirolimus?

"After careful review of the available evidence, our team at Power has assigned a rating of 2 for sirolimus' safety. This is because this is a Phase 2 trial - there are some studies that support its security but no research on how effective it may be."

Answered by AI

How many individuals are currently enrolled in this investigation?

"Affirmative, according to the details available on clinicaltrials.gov this study is seeking volunteers. It was first made public on August 17th 2023 and has since been updated for a final time on August 28th 2023. 30 individuals are needed from one single site for participation in the trial."

Answered by AI

Are there any opportunities for individuals to join this experiment?

"Correct. Data hosted on clinicaltrials.gov indicates that this medical experiment, first posted August 17th 2023, is actively enrolling participants. Thirty individuals need to be recruited from 1 clinic site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Steven Hays, MD 2023. "LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06018766.

All > Bronchiolitis Obliterans