Phase 2 N=18 Inhaled GM-CSF Therapy of Autoimmune PAP
Autoimmune Pulmonary Alveolar Proteinosis
Primary: Time to Rescue WLL — 18; 30 Months — p=0.0078
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=138 Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis
Autoimmune Pulmonary Alveolar Proteinosis
Primary: Absolute Change From Baseline of Alveolar-arterial Oxygen Concentration (A-a(DO2)) After 24 Weeks of Treatment — 28.6; 29.3; 32.0 mmHg — p=0.1688
Phase 2 N=2 Inhaled Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Hereditary Pulmonary Alveolar Proteinosis (PAP)
Hereditary Pulmonary Alveolar Proteinosis
Primary: Change in Time (Minutes) to Discontinuation of Exercise During a Standardized Treadmill Exercise Test — 17; 33 Percent Change
Phase 2 N=51 Autoantibody Reduction for Acute Exacerbations of Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis, Acute Fatal Form
Primary: %Survival — 44; 7 percentage of participants
N/A N=80 Anti-neutrophil Cytoplasmic Antibody in Interstitial Lung Disease.
Interstitial Lung Disease · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Primary: Death From All Causes — 10; 5 Participants
Phase 2 N=58 Autoantibody Reduction Therapy in Patients With Idiopathic Pulmonary Fibrosis
Ambulatory IPF
Primary: Autoantibodies to Human Epidermoid (HEp)-2 Cells — 288; 177 titer
Phase 2 N=9 Combined PEX, Rituximab and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations
IPF
Primary: Number of Participants With Respiratory and/or Hemodynamic Deteriorations — 1; 3 Participants
N/A N=120 Identification of Autoantigens in EGPA and Severe Eosinophilic Asthma
Churg-Strauss Syndrome · Eosinophilic Asthma · Eosinophilic Esophagitis
Primary: Number and Percentage of Patients With a Positive Autoantibody ELISA — 19; 4; 3; 4 Participants
N/A N=25 Rehabilitation of Idiopathic Pulmonary Fibrosis (IPF) Patients
Idiopathic Pulmonary Fibrosis
Primary: 6 Minute Walk Distance — -6.2; -15.3 meters
Phase 3 N=34 GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study
Alpha1-antitrypsin Deficiency
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Potentially Related to Presence of Particle Load in the GLASSIA Solution — 0; 0 Participants
Phase 2 N=17 Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies
Chronic Obstructive Pulmonary Disease · Emphysema
Primary: Percent Change of Circulating Anti-GRP78 IgG Levels — -17.0; -2.6 % change
Phase 3 N=236 Evaluating the Effectiveness of Prednisone, Azathioprine, and N-acetylcysteine in Patients With IPF
Pulmonary Fibrosis
Primary: Overall Change in Forced Vital Capacity — -0.18; -0.19 liters
Phase 2 N=35 Oral Pirfenidone for the Pulmonary Fibrosis of Hermansky-Pudlak Syndrome
Albinism · Inborn Errors of Metabolism · Oculocutaneous Albinism
Primary: Change in Forced Vital Capacity (36 Months) — -23.52; -20.93 % of predicted volume
Phase 2 N=23 Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus
Pemphigus
Primary: Number of Patients Achieving a Short- and Long-term Remission of Pemphigus — 23 Participants
Phase 2 N=57 Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)
Systemic Sclerosis-Associated PAH
Primary: Change From Baseline in Distance Walked During a Six Minute Walk Test — 23.6; 0.5 Meters — p=0.12
Phase 1 N=31 A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis
Primary: Proportion of Subjects Who Discontinue Study Drug Due to Adverse Events — 1; 0 Participants
Phase 2 N=132 A Randomized Trial of GM-CSF in Patients With ALI/ARDS
Respiratory Distress Syndrome, Adult
Primary: Ventilator-free Days During Days 1-28 — 10.8; 10.7 Days
Phase 2 N=40 Inhaled Tissue Plasminogen Activator for Acute Plastic Bronchitis
Plastic Bronchitis · Protein-Losing Enteropathies · Healthy
Primary: Primary Endpoint: Number of Subjects That Develop New, Active Bleeding — 0 Participants
Phase 2 N=20 Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD)
Graft-Versus-Host Disease (GVHD) Acute on Chronic
Primary: Number (Percentage) of Patients at Each Dosing Cohort Who Experience no Toxicity and in Whom Graft Versus Host Disease (GVHD) is Stable or Improved — 6; 2; 2 Participants
Phase 2 N=30 A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD
Graft-versus-host-disease · GVHD
Primary: Number of High Risk Patients Who Develop Steroid Refractory GVHD — 6 Participants
Phase 2 N=40 A Pilot Study of Alpha-1-Antitrypsin (AAT) in Steroid Refractory Acute Graft vs Host Disease
Graft vs Host Disease
Primary: Percentage of Patients That Respond to Treatment — 65 percentage of patients
Phase 2 N=10 Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction
Restrictive Chronic Lung Allograft Dysfunction · Lung Transplant Rejection
Primary: Tolerability of Pirfenidone — 3 Participants
N/A N=125 Families-At-risk for Interstitial Lung Disease Study
Interstitial Lung Disease · Idiopathic Pulmonary Fibrosis
Primary: Number of Participants With ILA (Interstitial Lung Abnormalities) — 85; 13 Participants
Phase 2 N=30 Sirolimus for Autoimmune Disease of Blood Cells
Autoimmune Pancytopenia · Autoimmune Lymphoproliferative Syndrome (ALPS) · Evans Syndrome
Primary: Number of Participants With Grade 3 and 4 Toxicities of Administration of Oral Sirolimus — 1 participants
Phase 2 N=20 Abatacept for the Treatment of Myositis-associated Interstitial Lung Disease
Myositis · Interstitial Lung Disease
Primary: % Predicted Forced Vital Capacity (FVC) Absolute Change — -1.70; -2.05 % predicted FVC — p=<0.05
N/A N=26 Immunotherapy of the Paraneoplastic Syndromes
Paraneoplastic Syndromes
Primary: Survival of Patients With Paraneoplastic Disease Who Are Treated With Tacrolimus — 48 months
Phase 2 N=10 Imaging Evaluation of PLN-74809 in Participants With IPF (PLN-74809)
Idiopathic Pulmonary Fibrosis
Primary: Primary Outcome — -0.0147; 0.0740 Unitless
Phase 3 N=43 CALIPSO: Calfactant for Acute Lung Injury in Pediatric Stem Cell Transplant and Oncology Patients
Acute Lung Injury
Primary: All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge — 15; 6 Participants
Phase 2 N=58 GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Primary: Surrogate Biomarker of Oxidative Stress by Mass Spectroscopy — -79.9; 13.3 micromole/M tyrosine
Phase 3 N=725 Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
Pneumonia, Bacterial
Primary: Number of Participants Surviving Through LFU Visit — 191; 196; 64; 57 Participants — p=0.4263