Phase 3 N=2,183 Asthma Exacerbation Study
Asthma
Primary: Number of Participants With 1 or More Severe Asthma Exacerbations — 186; 154 participants — p=0.036
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N/A N=1,899 Exacerbation Risk in Asthma
Asthma
Primary: Time to First Severe Exacerbation — 43.75; 49.43 Days — p=0.758
Phase 2 N=68 Symptom Clusters in Children With Exacerbation-prone Asthma
Asthma in Children
Primary: Change in Asthma Control Questionnaire (ACQ) Score — 0.52 score on a scale
Phase 3 N=254 Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations
Asthma
Primary: Asthma Exacerbations — 0.37; 0.48 exacerbations per year
Phase 4 N=52 Positive Expiratory Pressure for the Treatment of Acute Asthma in Children
Asthma
Primary: Change in Pulmonary Asthma Score (PAS) — 0.9; 0.4 mean PAS score
Phase 3 N=288 (CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)
Asthma
Primary: Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy — 22; 20; 25; 36 participants — p=0.066
Phase 4 N=49 Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
Asthma
Primary: Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15 — 59.56; 52.45 percentage of predicted
N/A N=222 Asthma Express: Bridging the Emergency to Primary Care in Underserved Children
Asthma
Primary: Symptom Days — 6.24; 4.82 symptom days over past 14 days — p=0.06
N/A N=25 Exacerbations in Severe Asthma Patients: Mechanisms and Biomarkers
Asthma
Primary: Percent Predicted FEV1 — 58.6; 56.3 % of predicted value — p=0.745
Phase 3 N=397 A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma
Asthma
Primary: Clinical Asthma Exacerbation (CAE) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CAE — 17 percentage of participants
Phase 3 N=308 Use of Dexamethasone in Pediatric Asthma Exacerbations
Asthma
Primary: Number of Participants Returning to Care Following Discharge From the Emergency Department — 14; 12 Participants
N/A N=22 Acute Effect of Mometasone on Beta-adrenergic Airway and Airway Vascular Relaxation in Severe Asthma
Asthma
Primary: Albuterol-induced Change in FEV1 — 0.27; 0.18; 0.32; 0.20 liters
Phase 3 N=945 The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room
Status Asthmaticus
Primary: Patients Hospitalization Rate — 82; 75 participants
Phase 3 N=47 Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)
Asthma, Exercise-Induced
Primary: Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction…
N/A N=141 A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation
Asthma
Primary: Number of Participants With Bronchodilation — 74; 67 Participants
Phase 3 N=1,437 TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
Asthma
Primary: 1_Change From Baseline in Pre-Dose Forced Expiratory Volume in the First Second (FEV1) at Week 26 — 0.229; 0.157; 0.274 Liter — p=0.003
Phase 3 N=251 Nebulized Fluticasone Propionate VS Oral Prednisone in Chinese Pediatric and Adolescent Subjects With an Acute Exacerbation of Asthma
Asthma
Primary: Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population — 188.77; 188.31 Litres per minute…
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 4 N=42 An Exploratory Study to Characterise Changes in Airway Inflammation, Symptoms, Lung Function and Reliever Use in Adult Asthma Patients
Airway Inflammation · Asthma
Primary: Fractional Exhaled Nitric Oxide (FeNO) — 8.67; 9.01 parts per billion (ppb)
N/A N=10 Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations
Asthma
Primary: Percent Forced Expiratory Volume in One Second (FEV1) — 90; 88 % FEV1
Phase 3 N=95 Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
Asthma
Primary: FEV1 Percent Predicted — 51.7; 52.6 percent predicted of FEV1
N/A N=16 Optimal Albuterol Regimens for Acute Asthma Exacerbations: DBRCT Pilot Study
Acute Asthma
Primary: %FEV1 — 20; 34; 26; 31 %-predicted
Phase 4 N=478 Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations
Asthma
Primary: Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5]) — 11.3; 21.0 Percent of adjusted prevalence — p=0.03
Phase 3 N=3,132 A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma
Asthma
Primary: Number of Participants With a Severe Asthma Exacerbation Event — 207; 266; 241; 276 Participants — p=<0.001
Phase 2 N=18 PEEP as Rescue Therapy for Asthmatics With Elevated BMI
Asthma
Primary: Central and Peripheral Elastance — 391; 461; 587; 334 cmH2O/L
Phase 3 N=62 Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)
Asthma, Exercise-Induced
Primary: Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)…
Phase 3 N=51 Montelukast in Exercise-Induced Bronchospasm - 2003 (0476-270)
Asthma, Exercise-Induced
Primary: Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)…
Phase 3 N=64 A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma
Asthma, Exercise-Induced
Primary: Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge — 6.95…
Phase 3 N=60 A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma
Exercise Induced Bronchospasm
Primary: Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge — 5.45…
N/A N=14 Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway
Asthma
Primary: Maximum Change From Baseline in Airway Blood Flow (Qaw) — -11.0; 14.1; 23.9; 25.5 change from baseline ( µl/min/ml) — p=< 0.001