A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (2.5 mcg and 5 mcg) Delivered Via Respimat® Inhaler Once Daily in the Evening Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Children (6 to 11 Years Old) With Severe Persistent Asthma

简要总结

主要结局

次要结局

• Peak Expiratory Flow (PEF) a.m. Change From Baseline(Baseline and 12 weeks)
• Trough FEV1 Change From Baseline(Baseline and 12 weeks)
• FVC Peak(0-3h) Change From Baseline(Baseline and 12 weeks)
• Trough FVC Change From Baseline(Baseline and 12 weeks)
• FEV1 AUC (0-3h) Change From Baseline(Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks)
• FVC AUC (0-3h) Change From Baseline(Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks)
• FEV1 Change From Baseline at Each Individual Timepoint(Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks)
• FVC Change From Baseline at Each Individual Timepoint(Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks)
• Control of Asthma as Assessed by ACQ-IA Total Score(Baseline and 12 weeks)
• ACQ-IA Total Score Responders(12 weeks)
• Use of PRN Rescue Medication Per Day(Baseline and 12 weeks)
• Use of PRN Rescue Medication During the Daytime(Baseline and 12 weeks)
• Use of PRN Rescue Medication During the Night-time(Baseline and 12 weeks)
• Peak Expiratory Flow (PEF) p.m. Change From Baseline(Baseline and 12 weeks)
• Peak Expiratory Flow (PEF) Variability Change From Baseline(Baseline and 12 weeks)
• FEV1 a.m. Change From Baseline(Baseline and 12 weeks)
• FEV1 p.m. Change From Baseline(Baseline and 12 weeks)
• Change From Baseline in Nighttime Awakenings(Baseline and 12 weeks)
• Change From Baseline in Morning Asthma Symptoms(Baseline and 12 weeks)
• Change From Baseline in Daytime Asthma Symptoms(Baseline and 12 weeks)
• Change From Baseline in Daytime Activity Limitations(Baseline and 12 weeks)
• Change From Baseline in Daytime Experiences of Shortness of Breath(Baseline and 12 weeks)
• Change From Baseline in Daytime Experiences of Wheeze or Cough(Baseline and 12 weeks)
• Change From Baseline in Asthma Symptom-free Days(Baseline and 12 weeks)