Evidence map›Paper›PMID 42310706›Full record

Trial reportRespiratory research2026

The LTI-01-2001 phase 2a trial of intrapleural LTI-01 in patients with infected, non-draining pleural effusions.

Carla R Lamb, Jason Akulian, Ali Musani, Samira Shojaee, Alexander Chen, Jonathan Kurman, Pushan Jani, Michal Senitko, Danish Ahmad, Momen Wahidi and 14 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04159831 (A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-ranging Study Evaluating LTI-01), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04159831 phase2completednot on this map

A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-ranging Study Evaluating LTI-01 (Single-chain Urokinase Plasminogen Activator, scuPA) in Patients With Infected, Non-draining Pleural Effusions

TypeinterventionalSponsorRein TherapeuticsRan2020 to 2022Enrolled44ConditionsPleural EffusionArmsLTI-01, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Carla R LambLahey Hospital and Medical Center, Pulmonary and Critical Care Medicine, Burlington, USA.
Jason AkulianDivision of Pulmonary Diseases and Critical Care Medicine, University of North Carolina, Chapel Hill, USA.
Ali MusaniPulmonary and Sleep Medicine, Lenox Hill Hospital, Donald and Barbara Zucker School of Medicine at Hofstra University, New York, USA.
Samira ShojaeeDivision of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt Medical Center, Nashville, USA.
Alexander ChenDivision of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, USA.
Jonathan KurmanDivision of Pulmonary & Critical Care, Medical College of Wisconsin, Milwaukee, USA.
Pushan JaniInterventional Pulmonology, UT Houston and Memorial Hermann-Texas Medical Center, Houston, USA.
Michal SenitkoDivision of Pulmonary, Critical Care and Sleep Medicine, University of Mississippi Medical Center, Jackson, USA.
Danish AhmadInterventional Pulmonology, Division of Pulmonary, Sleep and Critical Care Medicine, Fox Chase Cancer Center Lewis Katz School of Medicine at Temple University, Philadelphia, USA.
Momen WahidiDivision of Pulmonary and Critical Care, Northwestern University Feinberg School of Medicine, Chicago, USA.
Sikandar AnsariIntermountain Health LDS Hospital, Salt Lake City, USA.
Muhanned Abu-HijlehDivision of Pulmonary and Critical Care Medicine, Interventional Pulmonology, UT Southwestern Medical Center, Dallas, USA.
Kevin C MaPulmonary, Allergy and Critical Care, Perelman School of Medicine, The University of Pennsylvania, Philadelphia, USA.
Jonathan PuchalskiDepartment of Pulmonology, Physicians Alliance of Connecticut (PACT), Guilford, USA.
Lonny YarmusInterventional Pulmonology, the Johns Hopkins University School of Medicine, Baltimore, USA.
Fayez KheirPulmonary and Critical Care Medicine, Massachusetts General Hospital, Boston, USA.
Fabien MaldonadoDivision of Allery, Pulmonary and Critical Care Medicine, Vanderbilt University, Nashville, USA.
George ChengInterventional Pulmonology, The University of California San Diego, San Diego, USA.
Christian AlvaradoDepartment of Epidemiology and Biostatistics, School of Medicine, The University of Teas at Tyler, Tyler, USA.
Singh P KaranDepartment of Epidemiology and Biostatistics, School of Medicine, The University of Teas at Tyler, Tyler, USA.
Brian WindsorRein Therapeutics, Inc., Austin, USA.
Najib M RahmanOxford University Hospitals Oxford Respiratory Trials Unit NHS Trust, Oxford, UK.
Steven ShoemakerNicosof LLC, Erie, USA.
Steven IdellDepartment of Cellular and Molecular Biology, School of Medicine, The University of Texas at Tyler, Routes 271 and 155, Tyler, TX, 75708, USA. Steven.idell@uthct.edu.

Funding

Lung Therapeutics Inc. Consultancy
6 · The paper itself

Abstract

backgroundSingle chain urokinase (LTI-01) intrapleural enzymatic therapy (IET) was safe and promising in a phase 1 clinical trial to overcome failed drainage in patients with pleural infection. The LTI-01-2001 phase 2a trial was a randomized, double-blind, placebo-controlled, multi-center, dose-ranging study in hospitalized subjects with infected, non-draining pleural effusions.

methodsLTI-01, in doses of 400,000, 800,000 or 1,200,000 Units, or placebo was administered intrapleurally once daily for up to 3 days. The primary efficacy endpoint was incidence of treatment failure within 7 days of starting study medication. Treatment failure was defined as requiring alternative pleural therapy irrespective of subsequent treatment. Pleural opacification was a secondary endpoint and was assessed by CT imaging of the change in opacified area expressed as a percentage of the ipsilateral hemithorax (relative change) or absolute change in pleural opacification volume expressed in liters.

results40/43 enrolled patients received LTI-01 or placebo due to constraints of the COVID-19 pandemic. There was no significant difference in incidence of treatment failure between the LTI-01 and placebo groups (OR 1.04, 95% CI 0.24,4.44, P = 0.96) while two predetermined sensitivity analyses demonstrated trends of improved efficacy in the 400,000 U group (P = 0.052 and 0.147). The absolute (Liters; L) and relative change from baseline in opacity volume were - 0.28 L (p=0.035) and - 55.8% (P = 0.064) versus placebo in the 800,000 U group, with significant reduction in absolute opacification found in the 400,000 and all LTI-01-treated groups combined (P < 0.03, respectively). There were no safety signals of concern, nor were there any episodes of intrapleural or pulmonary bleeding in LTI-01-treated patients.

conclusionsNo statistically significant difference in the incidence of treatment failure was seen, potentially related to low recruitment. Trends towards efficacy were observed in predetermined sensitivity analyses at the 400,000 U dose of intrapleural LTI-01. Pleural opacification appeared most improved by the 800,000 U intrapleural LTI-01. A larger phase 2b trial is required to confirm these results or determine the efficacy of LTI-01 in patients with organizing, nondraining, infected pleural effusions.

trial registrationClinicalTrials.gov NCT04159831. Registration date: November 12, 2019.

Indexed as

Fibrinolytic AgentsPleural EffusionUrokinase-Type Plasminogen ActivatorAdultAgedAged, 80 and overDose-Response Relationship, DrugDouble-Blind MethodDrainageFemaleHumansMaleMiddle AgedTreatment OutcomeFibrinolytic AgentsUrokinase-Type Plasminogen ActivatorComplicated parapneumonic pleural effusionsEmpyemaFibrinolysisIntrapleural enzymatic therapyNondraining pleural effusionsPlasminogen activator inhibitor-1Single chain urokinase plasminogen activator

Identifiers

PMID42310706
PMCPMC13520383

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.