Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients on treatment with Spiriva Respimat and allows adverse events to be recorded and evaluated.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
COPD patients who require treatment with longacting anticholinergic
Exclusion criteria
Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies. Spiriva® Respimat® is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks | Baseline and after 6 weeks of treatment | Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the PF-10 Score After 6 Weeks | Baseline and after 6 weeks of treatment | Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition) |
| Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety | Baseline and after 6 weeks of treatment | Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications poor (1, 2), satisfactory (3, 4), good (5, 6), and excellent (7, 8)) |
| Patients' Satisfaction After 6 Weeks of Treatment | 6 weeks | Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment (very satisfied, satisfied, rather satisfied, neither satisfied nor unsatisfied, rather unsatisfied, unsatisfied, and very unsatisfied) |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | 1,280 |
| Total | 1,280 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 36 |
| Overall Study | Individual different reasons | 21 |
Baseline characteristics
| Characteristic | Spiriva® Respimat® 2 Puffs Once Daily at the Same Time |
|---|---|
| Age, Continuous | 65.5 Years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 500 Participants |
| Sex: Female, Male Male | 780 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,280 |
| serious Total, serious adverse events | 6 / 1,280 |
Outcome results
Primary
Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks
Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)
Time frame: Baseline and after 6 weeks of treatment
Population: There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks | 61.5 Percentage of participants |
Secondary
Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety
Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications poor (1, 2), satisfactory (3, 4), good (5, 6), and excellent (7, 8))
Time frame: Baseline and after 6 weeks of treatment
Population: There were 1260 patients who had evaluable PGE at both baseline and after 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety | 1.1 PGE scale points | Standard Deviation 1.2 |
Secondary
Change From Baseline in the PF-10 Score After 6 Weeks
Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)
Time frame: Baseline and after 6 weeks of treatment
Population: There were 1230 patients who had evaluable PF-10 measurement at both baseline and after 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | Change From Baseline in the PF-10 Score After 6 Weeks | 13.4 PF-10 score points | Standard Deviation 15.9 |
Secondary
Patients' Satisfaction After 6 Weeks of Treatment
Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment (very satisfied, satisfied, rather satisfied, neither satisfied nor unsatisfied, rather unsatisfied, unsatisfied, and very unsatisfied)
Time frame: 6 weeks
Population: There were 1260 patients who had evaluable PGE after 6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | Patients' Satisfaction After 6 Weeks of Treatment | Very satisfied | 433 Participants |
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | Patients' Satisfaction After 6 Weeks of Treatment | Satisfied | 551 Participants |
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | Patients' Satisfaction After 6 Weeks of Treatment | Rather satisfied | 145 Participants |
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | Patients' Satisfaction After 6 Weeks of Treatment | Neither / nor | 77 Participants |
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | Patients' Satisfaction After 6 Weeks of Treatment | Rather dissatisfied | 24 Participants |
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | Patients' Satisfaction After 6 Weeks of Treatment | Dissatisfied | 21 Participants |
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | Patients' Satisfaction After 6 Weeks of Treatment | Very dissatisfied | 9 Participants |