Clinical Trial Search

Primary: Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period — 0.99; 1.06; 1.05 Asthma attacks within episodes per year — p=0.510

Primary: Rate of Exacerbations Requiring Systemic Corticosteroids — 0.97; 0.95 events per years of follow-up

Primary: Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID. — 0.37; 0.21 mm/wk

Primary: Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours — 0.793; 1.950; 2.504; 3.236 Log base 2…

Primary: Peak Change From Baseline in FEV1 Within 3 Hours Post-dosing on Day 15 — 0.284; 0.261; 0.252; 0.237 Liter

Primary: Airway Wall Thickness — 1.5; 1.5; 1.4; 1.6 mm — p=0.2

Primary: Differential Response to the Three Therapies Based on Fixed Threshold Criteria for the Following Asthma Control Measures: Use of Oral Prednisone for Acute Asthma…

Primary: Maximum Percent Drop From Pre-allergen Baseline in Forced Expiratory Volume in 1 Second (FEV1) for Late-Phase Asthma Response (LAR) at Screening — 27.19; 20.47 percent…

Primary: Number of Participants in Each Arm With a Need for an Increase in Study Medication — 29; 29 Participants

Primary: Proportion of Patients With a Severe Asthma Exacerbation During 14 Days of Treatment — 7; 5 Participants — p=0.645

Primary: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants — 27.23; 24.26 Percentage of Days

Primary: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks. — 0.134; 0.293; 0.262 Liter — p=0.0005

Primary: Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study — 202; 406; 26; 55 Participants

Primary: Asthma Control — 1.857; 1.592; 1.792; 1.578 units on a scale — p=0.046

Primary: Change From Baseline in Average VAS Score Perceptions of Asthma - Over the Entire 14-day Treatment Period - Question #3 — 2.68; 1.63 score on a scale — p=0.385

Primary: Change in FEV1 — -0.40; 0.69; -0.59 percentage of change

Primary: Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period — -0.002; -0.001; -0.034; -0.031 Liters

Primary: Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb) — -35.3; -45.4; -61.4; -51.3 percentage of eNO — p=<0.001

Primary: Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period — 50.45; 49.75 percentage of days — p=0.63

Primary: Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 — 9.53; 9.15 Percent Change

Primary: Number of Participants Who Experienced One or More Adverse Events — 9; 3 Participants

Primary: Participants With Adverse Events — 9; 12; 0; 0 participants

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…

Primary: Change in Asthma Control Questionnaire (ACQ) Score — 0.52 score on a scale

Primary: Number of Participants Who Experienced At Least One Adverse Event — 2; 4; 6; 9 participants

Primary: Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo — 4.52; 6.95; 6.00; 0.66 Percentage of Predicted…

Primary: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14) — 0.3196; 0.3076; 0.2795; 0.2726 Liters — p=<0.0001

Primary: Safety: Relative Change From Baseline* in Forced Expiratory Volume in 1 s (FEV1) -- 15 Min Post-dose — 2.12; 0.26 percent change — p=0.113

Primary: Fractional Exhaled Nitric Oxide (FeNO) — 8.67; 9.01 parts per billion (ppb)

Primary: Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks — -5.85; 0.61; -5.24 Percent change