Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
Documentation of successful therapy with tiotropium (Spiriva Respimat; Spiriva (tiotropium 18 mcg capsules)) in COPD patients requiring long-acting bronchodilators: description of the most important outcome parameters according to the physicians assessment to determine the success of therapy. Such data are not yet available. Also collection of physicians assessments and patients assessments of efficacy and tolerability of Spiriva Respimat, Spiriva (tiotropium 18 mcg capsules).
Detailed description
Study Design: observational
Interventions
None listed
Sponsors
Pfizer
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
COPD patients requiring long-acting bronchodilators according to approved Summary of Product Characteristics (SPC) and guidelines
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Efficacy According to Physician | 6 - 12 weeks | Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined |
| Assessment of Efficacy According to Patient | 6 - 12 weeks | patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing) |
| Assessment of Tolerability According to Patient | 6 - 12 weeks | Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing) |
| Success of Treatment With Tiotropium According to Physician's Assessment | 6 - 12 weeks | Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful |
| Assessment of Tolerability According to Physician | 6 - 12 weeks | Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Global Evaluation at Visit 2 | after 6 - 12 weeks | Physician's global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6-12 weeks of treatment with Spiriva. |
| Physician's Global Evaluation at Visit 1 | 0 weeks | Physician's global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores Poor (1, 2), Satisfactory (3, 4), Good (5, 6) and Excellent (7, 8) prior to treatment with Spiriva. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spiriva® 18 Microgram/Spiriva® Respimat® 1 capsule/2 puffs once daily at the same time | 1,264 |
| Total | 1,264 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 25 |
| Overall Study | Lost to Follow-up | 28 |
| Overall Study | Other reason (not specified) | 40 |
Baseline characteristics
| Characteristic | Spiriva® 18 Microgram/Spiriva® Respimat® |
|---|---|
| Age, Continuous | 65.3 Years STANDARD_DEVIATION 10.5 |
| Age, Customized < 65 years | 569 Years |
| Age, Customized >= 65 years | 695 Years |
| Sex: Female, Male Female | 466 Participants |
| Sex: Female, Male Male | 798 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,264 |
| serious Total, serious adverse events | 5 / 1,264 |
Outcome results
Primary
Assessment of Efficacy According to Patient
patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
Time frame: 6 - 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Patient | Very good | 339 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Patient | Good | 620 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Patient | Satisfactory | 169 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Patient | Less satisfactory | 55 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Patient | Unsatisfactory | 35 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Patient | Missing | 46 Participants |
Primary
Assessment of Efficacy According to Physician
Physician's assessment of efficacy within categories (positive/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
Time frame: 6 - 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Physician | Very good | 342 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Physician | Good | 645 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Physician | Satisfactory | 172 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Physician | Less satisfactory | 44 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Physician | Unsatisfactory | 27 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Efficacy According to Physician | Missing | 34 Participants |
Primary
Assessment of Tolerability According to Patient
Patient-reported assessment within categories (Very good, good, satisfactory, less satisfactory, unsatisfactory, missing)
Time frame: 6 - 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Patient | Very good | 564 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Patient | Good | 567 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Patient | Satisfactory | 54 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Patient | Less satisfactory | 14 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Patient | Unsatisfactory | 17 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Patient | Missing | 48 Participants |
Primary
Assessment of Tolerability According to Physician
Physician's assessment of tolerability (positve/ negative), concurrent proportion of positive efficacy assessments by both physician and patient was determined
Time frame: 6 - 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Physician | Unsatisfactory | 13 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Physician | Missing | 34 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Physician | Very good | 601 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Physician | Good | 572 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Physician | Satisfactory | 35 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Assessment of Tolerability According to Physician | Less satisfactory | 9 Participants |
Primary
Success of Treatment With Tiotropium According to Physician's Assessment
Evaluation of important outcome parameters (pulmonary function, dyspnoe, health-related quality of life, exercise capacity, prevention of exacerbations) which were used for the physician´s decision to assess the treatment as successful
Time frame: 6 - 12 weeks
Population: All patients who were documented to have taken at least one dose of Spiriva®18 Microgram/Spiriva® Respimat® and had COPD requiring long-acting anticholinergics
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® 18 Microgram/Spiriva® Respimat® | Success of Treatment With Tiotropium According to Physician's Assessment | Dyspnoea | 452 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Success of Treatment With Tiotropium According to Physician's Assessment | Quality of life | 412 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Success of Treatment With Tiotropium According to Physician's Assessment | Patient's opinion | 235 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Success of Treatment With Tiotropium According to Physician's Assessment | Prevention of exacerbations | 106 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Success of Treatment With Tiotropium According to Physician's Assessment | Pulmonary function | 620 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Success of Treatment With Tiotropium According to Physician's Assessment | Exercise capacity | 618 Participants |
Secondary
Physician's Global Evaluation at Visit 1
Physician's global evaluation (PGE) of the patients' general condition at Visit 1 evaluated on an 8-point scale with the scores Poor (1, 2), Satisfactory (3, 4), Good (5, 6) and Excellent (7, 8) prior to treatment with Spiriva.
Time frame: 0 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® 18 Microgram/Spiriva® Respimat® | Physician's Global Evaluation at Visit 1 | Excellent | 8 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Physician's Global Evaluation at Visit 1 | Good | 294 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Physician's Global Evaluation at Visit 1 | Satisfactory | 755 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Physician's Global Evaluation at Visit 1 | Poor | 206 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Physician's Global Evaluation at Visit 1 | Missing | 1 Participants |
Secondary
Physician's Global Evaluation at Visit 2
Physician's global evaluation (PGE) of the patients' general condition at Visit 2 evaluated on an 8-point scale after approximately 6-12 weeks of treatment with Spiriva.
Time frame: after 6 - 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® 18 Microgram/Spiriva® Respimat® | Physician's Global Evaluation at Visit 2 | Poor | 31 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Physician's Global Evaluation at Visit 2 | Excellent | 61 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Physician's Global Evaluation at Visit 2 | Good | 737 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Physician's Global Evaluation at Visit 2 | Satisfactory | 407 Participants |
| Spiriva® 18 Microgram/Spiriva® Respimat® | Physician's Global Evaluation at Visit 2 | Missing | 28 Participants |