Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.
Detailed description
Purpose: Study Design:
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent prior to participation 2. Female and male patients = or \> 40 years of age 3. Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and requiring long-acting dual bronchodilation (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 agonist (LABA)) treatment according to approved Spiolto® Respimat® Summary of Product Characteristics (SmPC) and COPD Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendation
Exclusion criteria
1. Patients with contraindications according to Spiolto® Respimat® SmPC 2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months 3. Patients continuing Long-acting beta2 agonist and inhalative corticosteroids (LABA-iCS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta2 agonists 4. Patients for whom further follow-up is not possible at the enrolling site during the planned study period of approx. 6 weeks 5. Pregnancy and lactation 6. Patients currently listed for lung transplantation 7. Current participation in any clinical trial or any other non-interventional study of a drug or device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) | After approximately 6 weeks (visit 2) | Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment. The PF-10 used for assessing the primary outcome physical functioning is a subdomain of the validated Short Form 36 (SF-36 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with yes, limited a lot, yes, limited a little or no, not limited at all, with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with yes, limited a lot) and 30 (a patient answering all questions with no, not limited at all). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20. Higher scores indicate better physical functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 | Baseline (visit 1) and after approx. week 6 (visit 2) | The change in Physical functioning questionnaire (PF-10 ) score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the mean for change from baseline values across all patients was calculated. The PF-10 consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with yes, limited a lot, yes, limited a little or no, not limited at all, with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with yes, limited a lot) and 30 (a patient answering all questions with no, not limited at all). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20. Higher scores indicate better physical functioning. |
| Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (visit 1) and after approx.week 6 (visit 2) | The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent |
| Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 | After approx. 6 weeks (visit 2) of treatment initiation | A patient satisfaction questionnaire on how overall satisfied they were with the Spiolto® Respimat® treatment was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). |
| Patient Satisfaction With Inhaling From the Respimat® Device | After approx. 6 weeks (visit 2) of treatment initiation | A patient satisfaction questionnaire on how satisfied they were by inhaling with the Respimat® device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). |
| Patient Satisfaction With Handling of the Respimat® Inhalation Device | After approx. 6 weeks (visit 2) of treatment initiation | A patient satisfaction questionnaire on how satisfied they were with handling of the Respimat® inhalation device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied). |
Countries
Spain
Participant flow
Recruitment details
Open-label observational study, including Chronic Obstructive Pulmonary Disease (COPD) patients in Spain receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations. Questionnaire (quest.). 10-point increase of Physical functioning questionnaire (PF10 )
Pre-assignment details
All participants were screened for eligibility to participate in the study. Participants attended primary care centres which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered if any one of the specific entry criteria were not met.
Participants by arm
| Arm | Count |
|---|---|
| Spiolto® Respimat® Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines | 253 |
| Total | 253 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-evaluable PF10 quest. at visit 2 | 19 |
| Overall Study | Not Treated | 4 |
Baseline characteristics
| Characteristic | Spiolto® Respimat® | — |
|---|---|---|
| Age, Continuous | 68.41 Years STANDARD_DEVIATION 10.83 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 68 Participants | — |
| Sex: Female, Male Male | 185 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 253 |
| other Total, other adverse events | 0 / 253 |
| serious Total, serious adverse events | 1 / 253 |
Outcome results
Primary
Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)
Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment. The PF-10 used for assessing the primary outcome physical functioning is a subdomain of the validated Short Form 36 (SF-36 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with yes, limited a lot, yes, limited a little or no, not limited at all, with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with yes, limited a lot) and 30 (a patient answering all questions with no, not limited at all). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20. Higher scores indicate better physical functioning.
Time frame: After approximately 6 weeks (visit 2)
Population: Full Analysis Set (FAS): All screened patients with at least one documented administration of Spiolto® Respimat® and available PF-10 score at visit 1 and visit 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiolto® Respimat® | Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) | 66.2 Percentage of Patients (%) |
Secondary
Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2
A patient satisfaction questionnaire on how overall satisfied they were with the Spiolto® Respimat® treatment was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).
Time frame: After approx. 6 weeks (visit 2) of treatment initiation
Population: FAS who completed the questionnaire.14 patients with missing data were excluded from the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 | Very unsatisfied | 0 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 | Unsatisfied | 2 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 | Rather unsatisfied | 6 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 | Neither satisfied, nor unsatisfied | 15 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 | Rather satisfied | 27 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 | Satisfied | 127 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 | Very satisfied | 43 Participants |
Secondary
Patient Satisfaction With Handling of the Respimat® Inhalation Device
A patient satisfaction questionnaire on how satisfied they were with handling of the Respimat® inhalation device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).
Time frame: After approx. 6 weeks (visit 2) of treatment initiation
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Very unsatisfied | 0 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Unsatisfied | 2 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Rather unsatisfied | 4 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Neither satisfied, nor unsatisfied | 14 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Rather satisfied | 29 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Satisfied | 132 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Very satisfied | 53 Participants |
Secondary
Patient Satisfaction With Inhaling From the Respimat® Device
A patient satisfaction questionnaire on how satisfied they were by inhaling with the Respimat® device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).
Time frame: After approx. 6 weeks (visit 2) of treatment initiation
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device | Very unsatisfied | 1 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device | Unsatisfied | 3 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device | Rather unsatisfied | 2 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device | Neither satisfied, nor unsatisfied | 16 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device | Rather satisfied | 25 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device | Satisfied | 129 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device | Very satisfied | 58 Participants |
Secondary
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2
The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent
Time frame: Baseline (visit 1) and after approx.week 6 (visit 2)
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 1 | 2 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 2 | 48 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 3 | 57 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 4 | 49 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 5 | 35 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 6 | 31 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 7 | 7 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 8 | 5 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Week 6 (approx.) (Visit 2): Score 1 | 1 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Week 6 (approx.) (Visit 2): Score 2 | 5 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Week 6 (approx.) (Visit 2): Score 3 | 14 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Week 6 (approx.) (Visit 2): Score 4 | 42 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Week 6 (approx.) (Visit 2): Score 5 | 46 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Week 6 (approx.) (Visit 2): Score 6 | 83 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Week 6 (approx.) (Visit 2): Score 7 | 36 Participants |
| Spiolto® Respimat® | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Week 6 (approx.) (Visit 2): Score 8 | 7 Participants |
Secondary
The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2
The change in Physical functioning questionnaire (PF-10 ) score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the mean for change from baseline values across all patients was calculated. The PF-10 consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with yes, limited a lot, yes, limited a little or no, not limited at all, with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with yes, limited a lot) and 30 (a patient answering all questions with no, not limited at all). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20. Higher scores indicate better physical functioning.
Time frame: Baseline (visit 1) and after approx. week 6 (visit 2)
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiolto® Respimat® | The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 | 16.04 Unit on scale | Standard Deviation 18.18 |