Trial Outcomes & Findings for Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities (NCT NCT00621582)
NCT ID: NCT00621582
Last Updated: 2014-10-23
Results Overview
The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least). Represents number of participants who score ""good"" and ""excellent"" at visit 1 (0 weeks) and visit 3 (8 weeks)
COMPLETED
4918 participants
0 weeks (Visit 1) and 8 weeks (Visit 3)
2014-10-23
Participant Flow
There is a gap between the enrollment number (4922) and the started patients (treatment number, 4812), as some of the enrolled patients did not accept the treatment. the number of started patients was 4918, among which 106 patients prematurely discontinued
Participant milestones
| Measure |
Tiotropium Bromide
|
|---|---|
|
Overall Study
STARTED
|
4918
|
|
Overall Study
COMPLETED
|
4812
|
|
Overall Study
NOT COMPLETED
|
106
|
Reasons for withdrawal
| Measure |
Tiotropium Bromide
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Protocol Violation
|
57
|
|
Overall Study
Lost to Follow-up
|
24
|
|
Overall Study
issues not identified by investigators
|
18
|
Baseline Characteristics
Spiriva® 18µg Once Daily in Chinese COPD Patients of Different Disease Severities
Baseline characteristics by cohort
| Measure |
Tiotropium Bromide
n=4918 Participants
|
|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
1603 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
3313 participants
n=5 Participants
|
|
Sex/Gender, Customized
Missing information
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 weeks (Visit 1) and 8 weeks (Visit 3)Population: Sampling Method: Non-Probability Sample; conducted in primary care clinics.
The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least). Represents number of participants who score ""good"" and ""excellent"" at visit 1 (0 weeks) and visit 3 (8 weeks)
Outcome measures
| Measure |
Tiotropium Bromide
n=4918 Participants
|
|---|---|
|
Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)
Number of patients at visit 1
|
831 Participants
|
|
Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)
Number of patients at visit 3
|
4213 Participants
|
PRIMARY outcome
Timeframe: 8 weeks (Visit 3)Population: Full Analysis Set (FAS)
Patient tolerability assessment classified as "Unsatisfied", "Satisfied", "Good" and "Very Good"
Outcome measures
| Measure |
Tiotropium Bromide
n=4880 Participants
|
|---|---|
|
Patient Tolerability Assessment at Visit 3
Good
|
1570 Participants
|
|
Patient Tolerability Assessment at Visit 3
Very Good
|
3109 Participants
|
|
Patient Tolerability Assessment at Visit 3
Unsatisfied
|
5 Participants
|
|
Patient Tolerability Assessment at Visit 3
Satisfied
|
196 Participants
|
SECONDARY outcome
Timeframe: 2 weeks (Visit 2 and 8 weeks (Visit 3)The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; Represents number of participants who score ""good"" and ""excellent"" at visit 2 (2 weeks) and visit 3 (8 weeks)
Outcome measures
| Measure |
Tiotropium Bromide
n=4918 Participants
|
|---|---|
|
Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)
Number of patients at visit 2
|
4005 Participants
|
|
Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good)
Number of patients at visit 3
|
4694 Participants
|
SECONDARY outcome
Timeframe: 8 weeks (Visit 3)Population: Full Analysis Set (FAS)
The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8)
Outcome measures
| Measure |
Tiotropium Bromide
n=4880 Participants
|
|---|---|
|
Physician Tolerability Assessment at Visit 3
Poor
|
2 Participants
|
|
Physician Tolerability Assessment at Visit 3
Fair
|
90 Participants
|
|
Physician Tolerability Assessment at Visit 3
Good
|
1112 Participants
|
|
Physician Tolerability Assessment at Visit 3
Excellent
|
3676 Participants
|
Adverse Events
Tiotropium Bromide
Serious adverse events
| Measure |
Tiotropium Bromide
n=4918 participants at risk
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of chronic obstructive pulmonary disease
|
0.04%
2/4918 • 8 weeks
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.02%
1/4918 • 8 weeks
|
|
Cardiac disorders
Acute heart failure
|
0.02%
1/4918 • 8 weeks
|
|
Gastrointestinal disorders
Chronic gastrointestinal bleeding
|
0.02%
1/4918 • 8 weeks
|
|
General disorders
Multi-organ failure
|
0.02%
1/4918 • 8 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.02%
1/4918 • 8 weeks
|
|
Vascular disorders
Shock
|
0.02%
1/4918 • 8 weeks
|
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