Trial Outcomes & Findings for Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines (NCT NCT00615992)
NCT ID: NCT00615992
Last Updated: 2016-02-08
Results Overview
The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
COMPLETED
754 participants
Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)
2016-02-08
Participant Flow
Participant milestones
| Measure |
Spiriva® (Tiotropium Bromide)
Tiotropium bromide 18μg inhalation capsules once-daily
|
|---|---|
|
Overall Study
STARTED
|
754
|
|
Overall Study
COMPLETED
|
687
|
|
Overall Study
NOT COMPLETED
|
67
|
Reasons for withdrawal
| Measure |
Spiriva® (Tiotropium Bromide)
Tiotropium bromide 18μg inhalation capsules once-daily
|
|---|---|
|
Overall Study
Protocol Violation
|
67
|
Baseline Characteristics
Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines
Baseline characteristics by cohort
| Measure |
Spiriva® (Tiotropium Bromide)
n=687 Participants
Tiotropium bromide 18μg inhalation capsules once-daily
|
|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
269 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
414 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)Population: The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.
The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
Outcome measures
| Measure |
Spiriva® (Tiotropium Bromide)
n=687 Participants
Tiotropium bromide 18μg inhalation capsules once-daily
|
|---|---|
|
Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva
|
1.1 points on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)Population: The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.
The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
Outcome measures
| Measure |
Spiriva® (Tiotropium Bromide)
n=687 Participants
Tiotropium bromide 18μg inhalation capsules once-daily
|
|---|---|
|
Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva
|
1.1 points on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)Population: The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Outcome measures
| Measure |
Spiriva® (Tiotropium Bromide)
n=646 Participants
Tiotropium bromide 18μg inhalation capsules once-daily
|
|---|---|
|
Global Assessment of Efficacy by Patient
Very good
|
373 Participants
|
|
Global Assessment of Efficacy by Patient
Good
|
217 Participants
|
|
Global Assessment of Efficacy by Patient
Satisfactory
|
53 Participants
|
|
Global Assessment of Efficacy by Patient
Not satisfactory
|
3 Participants
|
SECONDARY outcome
Timeframe: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)Population: The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Outcome measures
| Measure |
Spiriva® (Tiotropium Bromide)
n=647 Participants
Tiotropium bromide 18μg inhalation capsules once-daily
|
|---|---|
|
Global Assessment of Tolerability by Patient
Very good
|
493 Participants
|
|
Global Assessment of Tolerability by Patient
Good
|
142 Participants
|
|
Global Assessment of Tolerability by Patient
Satisfactory
|
11 Participants
|
|
Global Assessment of Tolerability by Patient
Not satisfactory
|
1 Participants
|
SECONDARY outcome
Timeframe: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)Population: The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Outcome measures
| Measure |
Spiriva® (Tiotropium Bromide)
n=648 Participants
Tiotropium bromide 18μg inhalation capsules once-daily
|
|---|---|
|
Global Assessment of Efficacy by Physician
Very good
|
407 Participants
|
|
Global Assessment of Efficacy by Physician
Good
|
205 Participants
|
|
Global Assessment of Efficacy by Physician
Satisfactory
|
36 Participants
|
|
Global Assessment of Efficacy by Physician
Not satisfactory
|
0 Participants
|
SECONDARY outcome
Timeframe: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days)Population: The discrepancy between the total number of participants and the numbers analyzed for a certain parameter is due to missing data.
Rating scale ranging from very good (best value) to not satisfactory (worst value)
Outcome measures
| Measure |
Spiriva® (Tiotropium Bromide)
n=647 Participants
Tiotropium bromide 18μg inhalation capsules once-daily
|
|---|---|
|
Global Assessment of Tolerability by Physician
Very good
|
540 Participants
|
|
Global Assessment of Tolerability by Physician
Good
|
102 Participants
|
|
Global Assessment of Tolerability by Physician
Satisfactory
|
5 Participants
|
|
Global Assessment of Tolerability by Physician
Not satisfactory
|
0 Participants
|
Adverse Events
Spiriva® (Tiotropium Bromide)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER