Phase 3 N=41 Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma
Asthma
Primary: Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils — -84.4; 27.7 Percent change in MFI
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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 2 N=49 Oxidative Stress in Asthma
Asthma · Obesity
Primary: Percentage of Neutrophils in Peripheral Blood — 57.3; 55.4 percentage of neutrophils — p=0.53
Phase 2 N=58 Allergy Immunotherapy for the Reduction of Asthma
Wheezing · Asthma · Allergy
Primary: Asthma Severity as Measured by the Asthma Severity Score (Averaged up to 36 Months) — 21.95; 25.68; 27.72; 27.85 score on a scale — p=0.38
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
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
Phase 3 N=211 Characterization of the Role of Histamine in Children With Asthma
Asthma · Allergic Asthma · Non-allergic Asthma
Primary: Characterize Contribution of Histamine in Children With Asthma — 11253.24; 6464.20; 3539.67 flux units on a continuous scale
Phase 2 N=24 The Effect of Inhibition of B7-mediated Costimulation on Allergic Airway Inflammation in Mild Atopic Asthmatics
Atopic Asthma
Primary: Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge — 42; 19 percentage of cells
Early Phase 1 N=9 In Vitro Evaluation of a Novel Drug on Airway Epithelial Cells Obtained From Participants With Severe Asthma
Asthma
Primary: Concentration (pg/ml) of CXCL8 Cytokine in Cell Supernatant After Stimulation (IFN/TNF or IL13) and Treatment (VR588, FP or CP) Conditions in ALI Cultured Epithelial…
N/A N=33 Study on the Role of Treatment With Vitamin E on Asthmatic Responses in Allergic Asthmatics
Allergic Asthma
Primary: Effect of Natural-source d-α-tocopheryl Acetate on the Baseline and Allergen-induced Levels of F2-isoprostanes in the Bronchoalveolar Lavage Fluid (BAL)
Phase 2 N=18 Biomarkers of Irritant-Induced and Allergic Asthma
Asthma
Primary: Change in TSLP Gene Expression — 0.000197; 0.000035 Fold Change
Phase 4 N=333 A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)
Asthma
Primary: Rate of Asthma Exacerbations Over the 24 Week Treatment Period — 0.205; 0.258 exacerbations per 24 patient-week period
Early Phase 1 N=39 Defining and Treating Depression-related Asthma
Asthma · Depression · Childhood Asthma
Primary: FEV1 Percent Change Post-ipratropium — 10.8 percent change — p=0.032
N/A N=54 The Effectiveness of Montelukast on Atopic Dermatitis in Koreans
Atopic Dermatitis
Primary: Changes in SCORAD Index — -3.0; -5.7 units on a scale
Phase 2 N=20 Effect of Benralizumab in Atopic Dermatitis
Dermatitis, Atopic · Dermatitis · Eczema
Primary: Number of Allergen-induced Eosinophils in the Skin — 11.95; 71.15 cells/mm2
Phase 2 N=28 Study of the Inflammation and Airway Changes That Occur After Exposure to Allergen in Asthmatics
Asthma
Primary: Difference in Expression of Epithelial miRNAs (in Read Counts) 24 Hours After Allergen-challenge as Compared to 24 Hours After Diluent Challenge in Participants With…
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=21 Personalized Treatment Algorithms for Difficult-to-treat Asthma
Asthma in Children
Primary: Change in Composite Asthma Severity Index (CASI) — 5; 5; 5 score on a scale — p=0.52
Phase 4 N=419 Inner-City Anti-IgE Therapy for Asthma
Asthma
Primary: Maximum Number of Asthma Symptom Days — 1.48; 1.96 Days — p=<0.001
Phase 2 N=155 Environmental Control as Add-on Therapy in Childhood Asthma
Asthma
Primary: The Medication Treatment Step Assigned — 4.03; 4.05 score on a scale
Phase 2 N=30 A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Esophagitis
Primary: Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups — 0.6; -7.5 perecentage of eos per…
Phase 4 N=36 Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
Allergic Asthma
Primary: Change From Baseline in Total Subepithelial Eosinophils at the End of Week 78 (End of Treatment) — -5.807; -5.890; 1.555; -5.626 cells/mm^2
Phase 3 N=510 Prevention of Asthma With Levocetirizine 18 Month Treatment in Infants (12 - 24 Months) Suffering From Eczema (Atopic Dermatitis) and Sensitized to Grass Pollen and/or House Dust Mite (HDM)
Dermatitis, Atopic
Primary: Time to Onset of Asthma During the Treatment Period — NA; NA months — p==0.991
Phase 4 N=406 Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Asthma
Primary: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) — 190; 29; 187; 28 participants
Phase 2 N=30 A Study to Evaluate the Efficacy of MEDI-528 on Late Asthmatic Response With Atopic Asthma
Asthma
Primary: Effect of MEDI-528 on Late Asthmatic Response (LAR) After Inhaled Allergen Challenge at Day 7 — 21.26; -16.21 Percent — p=0.168
Early Phase 1 N=12 The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic Asthmatics
Asthma
Primary: The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells — 32800; 89100 number of cells/g of sputum
N/A N=18 Airway Smooth Muscle and Asthma Severity
Asthma
Primary: Difference in ASM Mass Between Groups
Phase 3 N=628 Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
Asthma
Primary: Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period — 0.45; 0.64 Exacerbations per patient per 24-weeks
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…
Phase 3 N=46 Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics
Asthma
Primary: Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge — 0.822; 6.468 Percent — p=0.0208