Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The primary objective of the study is to measure changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients being treated with Spiolto® Respimat® after approximately 6 weeks. A secondary objective is to evaluate the patient¿s general condition (physician¿s evaluation) at visit 1 (baseline visit at the start of the study) and at visit 2 (final visit at the end of the study, approx. 6 weeks after visit 1), as well as patient satisfaction with Spiolto® Respimat® at visit 2.
Interventions
DRUGSpiolto Respimat
Tiotropium bromide + Olodaterol
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 COPD 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 LABA- Inhalative Corticosteroides (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 (Approx.) (Visit 2). | after approximately 6 weeks | Therapeutic success defined as a minimum 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) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | Week 6 (approx.) (Visit 2) | At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were with handling of the Respimat® inhalation device |
| Changes in the PF-10 Score From Visit 1 to Visit 2 | baseline and approx. week 6 | 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). |
| General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Baseline (Visit 1) and Week 6 (approx.) (Visit 2) | Physician's Global Evaluation (PGE) score documented by physicians at visit 1 (baseline) and at visit 2 (approx. 6 weeks later). the PGE score documented from 1 to 8. The highest value (=8) representing an excellent general condition |
| Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | Week 6 (approx.) (Visit 2) | At Week 6 (approx.) (Visit 2) patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment. |
| Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | Week 6 (approx.) (Visit 2) | At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were by inhaling with the Respimat® device. |
Countries
Germany
Participant flow
Recruitment details
1737 patients were treated. Of these 1578 patients had both visits documented as well as filled in all questionnaires, thus being evaluable for analysis of primary and secondary endpoints .
Pre-assignment details
All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered to trial drug if any of the specific entry criteria was violated.
Participants by arm
| Arm | Count |
|---|---|
| Spiolto Respimat COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines | 1,737 |
| Total | 1,737 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Evaluable PF-10 questionnaire at visit1 | 151 |
| Overall Study | No evaluable PF-10 questionnaire at all | 8 |
Baseline characteristics
| Characteristic | Spiolto Respimat | — |
|---|---|---|
| Age, Continuous | 66.51 Years STANDARD_DEVIATION 10.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 747 Participants | — |
| Sex: Female, Male Male | 990 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 1,737 |
| other Total, other adverse events | 0 / 1,737 |
| serious Total, serious adverse events | 3 / 1,737 |
Outcome results
Primary
Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).
Therapeutic success defined as a minimum 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) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.
Time frame: after approximately 6 weeks
Population: Full analysis set (FAS): This analysis set consist of all screened patients with informed consent, date of registration, at least one documented administration of Spiolto® Respimat® \& available PF-10 score at visit 1\&2, \& confirmed main diagnosis of COPD in whom treatment with long-acting anticholinergics plus bronchodilators is indicated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiolto Respimat | Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2). | 51.52 Percentage of patients |
Secondary
Changes in the PF-10 Score From Visit 1 to Visit 2
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).
Time frame: baseline and approx. week 6
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiolto Respimat | Changes in the PF-10 Score From Visit 1 to Visit 2 | 11.63 Unit on Scale | Standard Deviation 19.04 |
Secondary
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2.
Physician's Global Evaluation (PGE) score documented by physicians at visit 1 (baseline) and at visit 2 (approx. 6 weeks later). the PGE score documented from 1 to 8. The highest value (=8) representing an excellent general condition
Time frame: Baseline (Visit 1) and Week 6 (approx.) (Visit 2)
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Baseline (Visit 1) : PGE score 1 | 1.20 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Baseline (Visit 1) : PGE score 2 | 11.28 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Baseline (Visit 1) : PGE score 3 | 22.69 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Baseline (Visit 1) : PGE score 4 | 30.04 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Baseline (Visit 1) : PGE score 5 | 18.82 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Baseline (Visit 1) : PGE score 6 | 11.91 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Baseline (Visit 1) : PGE score 7 | 3.61 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Baseline (Visit 1) : PGE score 8 | 0.44 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Week 6 (approx.) (Visit 2): Score 1 | 0.25 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Week 6 (approx.) (Visit 2): Score 2 | 3.68 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Week 6 (approx.) (Visit 2): Score 3 | 10.71 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Week 6 (approx.) (Visit 2): Score 4 | 18.12 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Week 6 (approx.) (Visit 2): Score 5 | 28.33 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Week 6 (approx.) (Visit 2): Score 6 | 24.97 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Week 6 (approx.) (Visit 2): Score 7 | 11.98 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Week 6 (approx.) (Visit 2): Score 8 | 1.71 Percentage of participants |
| Spiolto Respimat | General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. | Week 6 (approx.) (Visit 2): missing | 0.25 Percentage of participants |
Secondary
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2).
At Week 6 (approx.) (Visit 2) patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment.
Time frame: Week 6 (approx.) (Visit 2)
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | Very satisfied | 33.59 Percentage of participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | Satisfied | 48.86 Percentage of participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | Rather satisfied | 8.11 Percentage of participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | Neither satisfied nor dissatisfied | 3.99 Percentage of participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | Rather dissatisfied | 2.09 Percentage of participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | Dissatisfied | 2.66 Percentage of participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | Very dissatisfied | 0.63 Percentage of participants |
| Spiolto Respimat | Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). | Not answered | 0.06 Percentage of participants |
Secondary
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2).
At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were with handling of the Respimat® inhalation device
Time frame: Week 6 (approx.) (Visit 2)
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | Very satisfied | 33.08 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | Satisfied | 52.09 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | Rather satisfied | 9.82 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | Neither satisfied nor dissatisfied | 2.98 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | Rather dissatisfied | 0.82 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | Dissatisfied | 0.82 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | Very dissatisfied | 0.32 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). | Not answered | 0.06 percentage of participants |
Secondary
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2).
At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were by inhaling with the Respimat® device.
Time frame: Week 6 (approx.) (Visit 2)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | Very satisfied | 35.17 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | Satisfied | 52.34 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | Rather satisfied | 6.91 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | Neither satisfied nor dissatisfied | 3.49 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | Rather dissatisfied | 0.89 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | Dissatisfied | 0.76 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | Very dissatisfied | 0.32 percentage of participants |
| Spiolto Respimat | Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). | Not answered | 0.13 percentage of participants |