Phase 2 N=10 Mepolizumab As a Steroid-sparing Treatment Option in the Churg Strauss Syndrome
Churg Strauss Syndrome
Primary: Number of Participants With Indicated Side Effects — 3; 1; 0; 1 Participants
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N/A N=118 Mepolizumab Long-term Study to Assess Real World Safety and Effectiveness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Japan
Churg-Strauss Syndrome · Eosinophilic Granulomatosis With Polyangiitis
Primary: Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) — 69; 26; 42 Participants
Phase 3 N=100 Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921
Churg-Strauss Syndrome · Eosinophilic Granulomatosis With Polyangiitis
Primary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 98; 38 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
Phase 2 N=24 Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis
Chronic Rhinosinusitis (Diagnosis) · Nasal Polyps · Eosinophilia
Primary: Change in Nasal Polyp Score — .9; .3 score on a scale
N/A N=12 Role of Eosinophils in the Proliferation of Airway Smooth Muscle (ASM) Cells
Asthma
Primary: Fold Increase in ASM Proliferation Following Incubation With Eosinophils. — 2; 2 Fold increase in ASM cell proliferation — p=<0.05
Phase 3 N=136 A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
Churg-Strauss Syndrome
Primary: Number of Participants in Each Category of Accrued Duration of Remission — 55; 32; 8; 8 Participants — p=<0.001
Phase 4 N=83 Azithromycin in Bronchiolitis Obliterans Syndrome
Bronchiolitis Obliterans Syndrome · Graft Rejection · Lymphocytic Bronchiolitis
Primary: Prevalence of Bronchiolitis Obliterans Syndrome (BOS) — 5; 19 participants
Phase 3 N=295 Steroids In Eosinophil Negative Asthma
Asthma
Primary: Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. — 74; 35; 56; 12 Participants…
N/A N=30 Role of IL-5R Signaling in Non-eosinophil Upper Airway Cells in CRSwNP
Nasal Polyps · Aspirin-exacerbated Respiratory Disease
Primary: Number of Participants With Nasal Polyp Plasma Cell Transcriptome — 10; 10; 10 Participants
Phase 4 N=13 A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
ALLERGIC ASTHMA
Primary: Number of Participants With Change in Sputum Markers by End of Study — 0; 0 Participants
Early Phase 1 N=48 GSNOR Phenotyping/GSNO Challenge in Severe Asthma
Asthma
Primary: FeNO — 14.3; 34.3; 36.0; 49 parts per billion — p=<0.1
N/A N=31 Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment
Smoking
Primary: Airway Blood Flow — 2.13; 13.05 ΔQaw (ul/min/ml)
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
N/A N=55 Progression of Airway Obstruction in Childhood Asthma
Asthma
Primary: Airway Wall Thickness — 1.5; 1.5; 1.4; 1.6 mm — p=0.2
Phase 2 N=46 Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)
Asthma, Aspirin-Induced · Aspirin Exacerbated Asthma
Primary: Difference in PD2 (Provocative Dose of Aspirin That Elicits an Increase in Nasal Symptom Score of 2 During an Aspirin Challenge) on Prasugrel Versus Placebo — 79; 139 mg
Phase 4 N=95 Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)
Asthma, Aspirin-Induced · Chronic Rhinosinusitis With Nasal Polyps
Primary: Change From Baseline at Week 16 in Sinonasal Outcome Test -22 (SNOT-22) Score — -14.09; -4.37 points
N/A N=38 Eosinophilic Airway Inflammation and Mepolizumab
Asthma
Primary: The Primary Endpoint of the Study is the Percent of Eosinophils in the Bronchoalveolar Lavage Fluid After Segmental Allergen Challenge, Before and After Mepolizumab…
Phase 3 N=108 Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES)
Hypereosinophilic Syndrome
Primary: Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period — 56; 28 Percentage of participants…
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
Phase 4 N=30 Mepolizumab for the Treatment of Chronic Cough With Eosinophilic Airways Diseases
Chronic Cough · Eosinophilic Bronchitis · Asthma
Primary: Change From Baseline in 24-hour Cough Frequency at 14 Weeks — 17.0; 17.0; 12.6; 10.6 Coughs/hour — p=0.99
Phase 3 N=158 Scleroderma Lung Disease
Lung Diseases · Pulmonary Fibrosis · Systemic Scleroderma
Primary: Forced Vital Capacity — 66.6; 65.6 % of predicted
Phase 4 N=23 Steroid Treatment for Hypereosinophilic Syndrome
Eosinophilia · Hypereosinophilic Syndrome · Leukocyte Disorder
Primary: Mean Percent Change in Eosinophil Count After Glucocorticoid Challenge — -69.6; -13.6 percentage of eosinophil count
N/A N=7 Imaging Study of the Lungs During an Allergic Asthma Attack
Asthma · Atopy
Primary: Percentage Change in the Ratio of Mean-normalized Perfusion Within Ventilation Defective Regions Relative to Outside — -17.8 percentage
N/A N=18 Immune Dysfunction in Allergic Asthma
Asthma
Primary: Anti-KLH Antibody. This is Measured by ELISA and Expressed as ELISA Units Which Are Derived by Dilution of Serum Samples Until the Result Falls on a Linear Portion of…
Phase 4 N=313 Singulair(R) In Asthma And Allergic Rhinitis (0476-383)
Asthma
Primary: Asthma Control — 312; 72; 0; 229 Participants
Phase 3 N=26 Benralizumab for Eosinophilic Gastritis (BEGS)
Eosinophilic Gastritis or Gastroenteritis
Primary: Percent of Patients in Histological Remission (<30 Eos/Hpf) — 77; 8 percentage of participants — p=0.0001
Phase 3 N=169 Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)
Nasal Polyps
Primary: Mean Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 - ITT Population Excluding Medipharma Managed Sites — -0.62; -0.19 Scores on a Scale…
Phase 2 N=60 Preschool Wheeze: Inflammation/Infection Guided Management
Asthma
Primary: Number of Unscheduled Healthcare Visits (UHCV) — 0.5; 0.5 number of visits — p=0.05
Phase 2 N=45 Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis
Wegener's Granulomatosis
Primary: Remission of Vasculitis — 95 Percentage of participants