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 48 Weeks in Children (6 to 11 Years Old) With Moderate Persistent Asthma

简要总结

主要结局

次要结局

• Trough FEV1 Change From Baseline(Baseline and Week 24, Baseline and Week 48.)
• FEV1 Peak (0-3h) at Week 48 Change From Baseline(Baseline and Week 48.)
• 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 week 24)
• 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 24 weeks)
• FVC Peak(0-3h) Change From Baseline(Baseline and Week 24, Baseline and Week 48.)
• 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 Week 24)
• Trough FVC Change From Baseline(Baseline and Week 24, Baseline and Week 48)
• 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 24 weeks)
• Use of PRN (Pro re Nata) Rescue Medication Per Day(Baseline and Week 24, Baseline and Week 48.)
• Use of PRN Rescue Medication During Daytime(Baseline and Week 24, Baseline and Week 48.)
• Use of PRN Rescue Medication During Nighttime(Baseline and Week 24, Baseline and Week 48.)
• Peak Expiratory Flow (PEF) a.m. Change From Baseline(Baseline and Week 24, Baseline and Week 48.)
• PEF p.m. Change From Baseline(Baseline and Week 24, Baseline and Week 48.)
• PEF Variability Change From Baseline(Baseline and Week 24, Baseline and Week 48.)
• FEV1 a.m Change From Baseline(Baseline and Week 24, Baseline and Week 48.)
• FEV1 p.m. Change From Baseline(Baseline and Week 24, Baseline and Week 48.)
• ACQ-IA Total Score(Weeks 24 and 48.)
• ACQ-IA Responder Analysis(Weeks 24 and 48)
• PAQLQ(S) Total Score(Weeks 24 and 48.)
• PAQLQ(S) Symptom Domain Score(Weeks 24 and 48.)
• PAQLQ(S) Activity Limitation Domain Score(Weeks 24 and 48.)
• PAQLQ(S) Emotional Function Domain Score(Weeks 24 and 48.)
• Responders in PAQLQ(S) at Weeks 24 and 48(Weeks 24 and 48.)
• Change From Baseline in Nighttime Awakenings(Baseline and Week 24, Baseline and Week 48.)
• Change From Baseline in Morning Asthma Symptoms(Baseline and Week 24, Baseline and Week 48.)
• Change From Baseline in Daytime Asthma Symptoms(Baseline and Week 24, Baseline and Week 48.)
• Change From Baseline in Daytime Activity Limitations(Baseline and Week 24, Baseline and Week 48.)
• Change From Baseline in Daytime Experiences of Shortness of Breath(Baseline and Week 24, Baseline and Week 48.)
• Change From Baseline in Daytime Experiences of Wheeze or Cough(Baseline and Week 24, Baseline and Week 48.)
• Change From Baseline in Asthma Symptom-free Days(Baseline and Week 24, Baseline and Week 48.)