Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
Real-world data on the effects of a fixed-dose combination Long-acting beta agonists + long-acting antimuscarinic agent (LABA+LAMA) therapy with tiotropium and olodaterol administered in a single device, in COPD patients who need treatment with two long-acting bronchodilators, is not available. This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto Respimat according to the approved Summary of Product Characteristics (SmPC).
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 with more or equal to 40 years of age 3. Patients diagnosed with COPD and requiring long-acting dual bronchodilation (LAMA + LABA) treatment according to approved Spiolto Respimat Summary of Product Characteristics (SmPC) and chronic obstructive pulmonary disease (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 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 After Approximately 6 Weeks. | Approximately 6 weeks | The therapeutic success was defined as a minimum of 10- point increase in the Physical Functioning (PF-10) score between visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1), having approximately time period of 6 weeks between the evaluated questionnaires. PF-10 score measures changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2) | Baseline and week 6 | Change in PF-10 score was determined by taking into account the individual change of each patient between visit 1 and visit 2. The PF-10 used for assessing the primary outcome is a sub-domain of the validated Short Form (SF)-36 quality of life questionnaire and consists of 10 questions evaluating the experienced restrictions while conducting usual activities. Each question of the PF-10 may 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, respectively. The scores will be summed up between 10 and 30. The final sum of the individual scores was standardized to a range of 0 to 100 using the formula: 100\*(sum-10)/20. The lower the score the more disability. The higher the score the less disability. If less than half of the scale items were missing, missing values were replaced with the mean of the other values. If half or more than half was missing, no score was calculated. |
| General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Baseline and week 6 | This outcome measures general condition of the patient evaluated by the physician (PGE score) at visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1) evaluated on an 8-point scale with the scores Poor (1,2), Satisfactory (3, 4), Good (5, 6) and Excellent (7, 8). More the score, the better is the general condition of patient. |
| Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Approximately 6 weeks | At visit 2 patients were asked for their overall satisfaction with the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases. |
| Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Approximately 6 weeks | At visit 2 patients were asked how satisfied they were with inhaling from the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases. |
| Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Approximately 6 weeks | At visit 2 patients were asked how satisfied they were with handling the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases. |
Countries
Austria, Czechia, Hungary, Israel, Romania, Russia, Slovakia, Slovenia, Switzerland
Participant flow
Recruitment details
This is an open label observational study in Chronic Obstructive Pulmonary Disease (COPD) patients from 534 investigational sites in 9 countries.
Pre-assignment details
All subjects were screened for eligibility to participate in the trial. Subjects attended specialist sites which would then ensure that all subjects met all inclusion/exclusion criteria. Subjects were not to be entered to trial if any one of the specific entry criteria were not met.
Participants by arm
| Arm | Count |
|---|---|
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram Patients with Chronic Obstructive Pulmonary Disease (COPD) included in this group were treated with Spiolto® Respimat®, Tiotropium/ Olodaterol 2.5 microgram/ 2.5 microgram, inhalation solution for 6 weeks. | 7,443 |
| Total | 7,443 |
Baseline characteristics
| Characteristic | Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | — |
|---|---|---|
| Age, Continuous | 65.07 Years STANDARD_DEVIATION 9.33 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2349 Participants | — |
| Sex: Female, Male Male | 5094 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 7,443 |
| other Total, other adverse events | 0 / 7,443 |
| serious Total, serious adverse events | 5 / 7,443 |
Outcome results
Primary
Percentage of Patients With Therapeutic Success After Approximately 6 Weeks.
The therapeutic success was defined as a minimum of 10- point increase in the Physical Functioning (PF-10) score between visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1), having approximately time period of 6 weeks between the evaluated questionnaires. PF-10 score measures changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients.
Time frame: Approximately 6 weeks
Population: Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Percentage of Patients With Therapeutic Success After Approximately 6 Weeks. | 67.76 Percentage of participants (%) |
Secondary
Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2)
Change in PF-10 score was determined by taking into account the individual change of each patient between visit 1 and visit 2. The PF-10 used for assessing the primary outcome is a sub-domain of the validated Short Form (SF)-36 quality of life questionnaire and consists of 10 questions evaluating the experienced restrictions while conducting usual activities. Each question of the PF-10 may 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, respectively. The scores will be summed up between 10 and 30. The final sum of the individual scores was standardized to a range of 0 to 100 using the formula: 100\*(sum-10)/20. The lower the score the more disability. The higher the score the less disability. If less than half of the scale items were missing, missing values were replaced with the mean of the other values. If half or more than half was missing, no score was calculated.
Time frame: Baseline and week 6
Population: Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2) | 16.62 Score on scale | Standard Deviation 17.87 |
Secondary
General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2).
This outcome measures general condition of the patient evaluated by the physician (PGE score) at visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1) evaluated on an 8-point scale with the scores Poor (1,2), Satisfactory (3, 4), Good (5, 6) and Excellent (7, 8). More the score, the better is the general condition of patient.
Time frame: Baseline and week 6
Population: Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 7 at visit 1 | 203 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 8 at visit 1 | 39 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 1 at visit 1 | 96 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 2 at visit 1 | 754 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 3 at visit 1 | 1907 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 4 at visit 1 | 2159 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 5 at visit 1 | 1317 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 6 at visit 1 | 743 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 1 at visit 2 | 0 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 2 at visit 2 | 53 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 3 at visit 2 | 261 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 4 at visit 2 | 887 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 5 at visit 2 | 1772 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 6 at visit 2 | 2458 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 7 at visit 2 | 1451 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2). | Score 8 at visit 2 | 335 Participants |
Secondary
Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
At visit 2 patients were asked for their overall satisfaction with the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
Time frame: Approximately 6 weeks
Population: Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Very dissatisfied | 26 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Not answered | 5 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Very satisfied | 2847 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Satisfied | 2998 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Rather satisfied | 890 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Neither satisfied nor dissatisfied | 307 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Rather dissatisfied | 93 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Dissatisfied | 52 Participants |
Secondary
Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
At visit 2 patients were asked how satisfied they were with handling the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
Time frame: Approximately 6 weeks
Population: Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Not answered | 17 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Very satisfied | 3086 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Satisfied | 2988 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Rather satisfied | 794 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Neither satisfied nor dissatisfied | 239 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Rather dissatisfied | 55 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Dissatisfied | 30 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Very dissatisfied | 9 Participants |
Secondary
Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
At visit 2 patients were asked how satisfied they were with inhaling from the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.
Time frame: Approximately 6 weeks
Population: Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Very satisfied | 3143 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Satisfied | 3021 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Rather satisfied | 716 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Neither satisfied nor dissatisfied | 228 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Rather dissatisfied | 48 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Dissatisfied | 34 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Very dissatisfied | 11 Participants |
| Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram | Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks) | Not answered | 17 Participants |