Efficacy and Safety of 2 Doses of Tiotropium Via Respimat Compared to Placebo in Adolescents With Moderate Persistent Asthma

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo Respimat	Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
Tio R2.5	Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
Tio R5	Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler.

Participant Flow:   Overall Study

	Placebo Respimat	Tio R2.5	Tio R5
STARTED	138	125	135
COMPLETED	132	115	129
NOT COMPLETED	6	10	6
Not Treated	0	0	1
Adverse Event	2	0	0
Lack of Efficacy	0	1	0
Protocol Violation	3	0	1
Withdrawal by Subject	0	4	1
Other reason not defined above	1	5	3

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set which included all randomised patients who were dispensed trial medication and received at least one documented dose of trial medication.

Reporting Groups

	Description
Placebo Respimat	Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
Tio R2.5	Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
Tio R5	Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
Total	Total of all reporting groups

Baseline Measures

	Placebo Respimat	Tio R2.5	Tio R5	Total
Overall Participants Analyzed  [Units: Participants]	138	125	134	397
Age  [Units: Years] Mean (Standard Deviation)	14.2  (1.7)	14.2  (1.8)	14.5  (1.6)	14.3  (1.7)
Gender  [Units: Participants]
Female	50	44	45	139
Male	88	81	89	258

1.  Primary:

FEV1 peak0-3 Change From Baseline   [ Time Frame: Baseline and 24 weeks ]

2.  Secondary:

Trough FEV1 Change From Baseline   [ Time Frame: Baseline and 24 weeks ]

3.  Secondary:

FVC peak0-3 Change From Baseline   [ Time Frame: Baseline and 24 weeks ]

4.  Secondary:

Trough FVC Change From Baseline   [ Time Frame: Baseline and 24 weeks ]

5.  Secondary:

FEV1 AUC (0-3h) Change From Baseline   [ Time Frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks ]

6.  Secondary:

FVC AUC (0-3h) Change From Baseline   [ Time Frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks ]

7.  Secondary:

FEF25-75 Change From Baseline   [ Time Frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks ]

8.  Secondary:

Use of PRN Rescue Medication During the Daytime   [ Time Frame: Baseline and Week 24 ]

9.  Secondary:

Use of PRN Rescue Medication During the Night-time   [ Time Frame: Baseline and week 24 ]

10.  Secondary:

Use of PRN Rescue Medication During the Day   [ Time Frame: Baseline and week 24 ]

11.  Secondary:

Control of Asthma as Assessed by ACQ Total Score   [ Time Frame: Baseline and week 24 ]

12.  Secondary:

ACQ Total Score Responders   [ Time Frame: Week 24 ]

13.  Secondary:

Control of Asthma as Assessed by ACQ6   [ Time Frame: Baseline and week 24 ]

14.  Secondary:

ACQ6 Responders   [ Time Frame: Week 24 ]

15.  Secondary:

Time to First Severe Asthma Exacerbation During the 48 Week Treatment Period   [ Time Frame: 48 weeks ]

16.  Secondary:

Time to First Asthma Exacerbation During the 48 Week Treatment Period   [ Time Frame: Week 48 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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