Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The purpose of the study is to measure changes in physical functioning in chronic obstructive pulmonary disease (COPD) patients being treated with Spiolto® Respimat® after approximately 6 weeks in routine clinical practice.
Detailed description
Purpose:
Interventions
observations taken in a period of approximately 6 weeks
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
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 = 40 years of age 3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto® Respimat® SmPC and therapeutic plan recommendation
Exclusion criteria
1. Patients with contraindications according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) 2. Patients who have been treated with a LABA/LAMA combination (free and fixed dose) in the previous 6 months 3. Patients continuing LABA-Inhalative Corticosteroids (ICS) treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-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 | 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 sub-domain 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 Median 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 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 median for change from baseline values across all subjects was calculated. |
| 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® | After approx. 6 weeks of treatment initiation | Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2). |
| Patient Satisfaction With Inhaling From the Respimat® Device | After approx. 6 weeks of treatment initiation | Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2) |
| Patient Satisfaction With Handling of the Respimat® Inhalation Device | After approx. 6 weeks of treatment initiation | Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2). |
Countries
Italy
Participant flow
Recruitment details
Patient with chronic Obstructive Pulmonary Disease receiving treatment Spiolto® Respimat® were enrolled between July 2017 and May 2018. 309 screened and 3 patient violated inclusion/exclusion criteria were excluded, 306 entered the trial
Pre-assignment details
All participants were screened for eligibility to participate in the study. Participants attended specialist sites 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. Physical Functioning patient questionnaire (PF10)
Participants by arm
| Arm | Count |
|---|---|
| Spiolto Respimat Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines | 306 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Evaluable PF10 questionnaire at visit1 | 28 |
Baseline characteristics
| Characteristic | Spiolto Respimat | — |
|---|---|---|
| Age, Continuous | 71.04 Years STANDARD_DEVIATION 8.81 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 90 Participants | — |
| Sex: Female, Male Male | 216 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 306 |
| other Total, other adverse events | 0 / 306 |
| serious Total, serious adverse events | 2 / 306 |
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 sub-domain 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
Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed PF-10 questionnaire at both study visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiolto Respimat | Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2) | 52.52 Percentage of Participants (%) |
Secondary
Patient Overall Satisfaction With Spiolto® Respimat®
Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2).
Time frame: After approx. 6 weeks of treatment initiation
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® | Very satisfied | 31 Participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® | Satisfied | 111 Participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® | Rather satisfied | 98 Participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® | Neither satisfied nor dissatisfied | 29 Participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® | Rather dissatisfied | 5 Participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® | Dissatisfied | 0 Participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® | Very dissatisfied | 2 Participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® | Questionnaire not completed | 2 Participants |
Secondary
Patient Satisfaction With Handling of the Respimat® Inhalation Device
Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2).
Time frame: After approx. 6 weeks of treatment initiation
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Very satisfied | 57 Participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Satisfied | 121 Participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Rather satisfied | 70 Participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Neither satisfied nor dissatisfied | 19 Participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Rather dissatisfied | 4 Participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Dissatisfied | 5 Participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Very dissatisfied | 0 Participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device | Questionnaire not completed | 2 Participants |
Secondary
Patient Satisfaction With Inhaling From the Respimat® Device
Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2)
Time frame: After approx. 6 weeks of treatment initiation
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device | Dissatisfied | 1 Participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device | Very dissatisfied | 1 Participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device | Very satisfied | 47 Participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device | Satisfied | 119 Participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device | Rather satisfied | 83 Participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device | Neither satisfied nor dissatisfied | 23 Participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device | Rather dissatisfied | 2 Participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device | Questionnaire not completed | 2 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 | 5 Participants |
| Spiolto Respimat | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 3 | 69 Participants |
| Spiolto Respimat | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 4 | 72 Participants |
| Spiolto Respimat | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 5 | 65 Participants |
| Spiolto Respimat | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 6 | 46 Participants |
| Spiolto Respimat | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 7 | 19 Participants |
| Spiolto Respimat | Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 | Baseline (Visit 1) : PGE score 8 | 0 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 | 0 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 | 2 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 | 18 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 | 32 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 | 65 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 | 113 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 | 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 8 | 6 Participants |
Secondary
The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2
The change in 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 median for change from baseline values across all subjects was calculated.
Time frame: Baseline (visit 1) and after approx. week 6 (visit 2)
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Spiolto Respimat | The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 | 10 Unit on scale |