Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The primary objective of this Non Interventional Study is to measure changes in physical functioning, a surrogate for physical activity and exercise capacity, in COPD patients on treatment with Spiolto® Respimat® in routine daily treatment after approximately 6 weeks. A secondary objective is to evaluate the patient's general condition (physician's evaluation) from Visit 1 (baseline visit at the start of the study) to 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 Chronic Obstructive Pulmonary Disease (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 Long-acting beta2 adrenoceptor agonist\\Long-acting muscarinic antagonist (LABA/LAMA) combination (free and fixed dose) in the previous 6 weeks. 3. Patients continuing Long-acting beta2 adrenoceptor agonist Inhalative Corticosteroids (LABA-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 Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline | Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later) | Therapeutic success is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain 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 scores over the 10 questions will be summed, resulting 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 will be standardized to a range of 0 to 100 using the following formula: 100\*(sum-10)/20. Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later) | Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later) | Change in PF-10 score was determined by taking into account the individual change of each patient between Visit 1 and Visit 2. PF questionnaire, is a sub-domain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain 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 scores over the 10 questions will be summed, resulting 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 will be standardized to a range of 0 to 100 using the following formula: 100\*(sum-10)/20. |
| General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later) | The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8(excellent). PGE will be completed before and approx. 6 weeks after treatment initiation. Count of patients with PGE score 2, 3, 4, 5, 6, 7, 8 are presented for Visit 1 and Visit 2. |
| Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction | Visit 2 (approx. 6 weeks post baseline) | A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented. |
| Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device | Visit 2 (approx. 6 weeks post baseline) | A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented. |
| Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device | Visit 2 (approx. 6 weeks post baseline) | A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented. |
Countries
Belgium, Denmark, Luxembourg, Netherlands, Portugal, Sweden
Participant flow
Recruitment details
This was an open-label observational study conducted in 6 countries, enrolling consented Chronic Obstructive Pulmonary Disorder (COPD) patients who received treatment with Spiolto® Respimat® according to the approved summary of product characteristics (SmPc).
Pre-assignment details
Patients were enrolled consecutively and were followed over an observational period of approximately 6 weeks, which was the average time between two medical consultations
Participants by arm
| Arm | Count |
|---|---|
| Tiotropium + Olodaterol FDC Patients were administered Tiotropium + olodaterol fixed-dose combination (FDC) using the Respimat® inhaler (Spiolto® Respimat® 2.5 microgram/2.5 microgram) as an inhalation solution.
Tiotropium + olodaterol FDC is an aqueous solution of tiotropium and olodaterol contained in a cartridge. One cartridge is used per inhaler, which is inserted into the device prior to first use | 127 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | General exclusion | 3 |
| Overall Study | Informed consent withdrawal | 1 |
| Overall Study | Loss of contact | 4 |
| Overall Study | Missing | 3 |
| Overall Study | Other reason | 5 |
| Overall Study | Patients wish to withdraw | 2 |
Baseline characteristics
| Characteristic | Tiotropium + Olodaterol FDC | — |
|---|---|---|
| Age, Continuous | 68.81 years STANDARD_DEVIATION 9.39 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 78 Participants | — |
| Sex: Female, Male Male | 49 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 127 |
| other Total, other adverse events | 0 / 127 |
| serious Total, serious adverse events | 0 / 127 |
Outcome results
Primary
Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline
Therapeutic success is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain 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 scores over the 10 questions will be summed, resulting 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 will be standardized to a range of 0 to 100 using the following formula: 100\*(sum-10)/20. Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented
Time frame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
Population: Full analysis set (FAS): Patients that were enrolled, registered and received at least one dose of treatment with Spiolto® Respimat® and had baseline and week 6 visit documented as well as completed all questionnaires were included in FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium + Olodaterol FDC | Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline | 44.90 percentage of participants |
Secondary
Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)
Change in PF-10 score was determined by taking into account the individual change of each patient between Visit 1 and Visit 2. PF questionnaire, is a sub-domain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain 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 scores over the 10 questions will be summed, resulting 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 will be standardized to a range of 0 to 100 using the following formula: 100\*(sum-10)/20.
Time frame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tiotropium + Olodaterol FDC | Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later) | 7.64 scores on a scale | Standard Deviation 17.6 |
Secondary
General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)
The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8(excellent). PGE will be completed before and approx. 6 weeks after treatment initiation. Count of patients with PGE score 2, 3, 4, 5, 6, 7, 8 are presented for Visit 1 and Visit 2.
Time frame: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 1_score (2) | 7 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 2_score (2) | 1 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 1_score (3) | 18 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 2_score (3) | 14 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 1_score (4) | 28 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 2_score (4) | 14 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 1_score (5) | 18 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 2_score (5) | 14 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 1_score (6) | 19 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 2_score (6) | 33 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 1_score (7) | 15 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 2_score (7) | 20 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 1_score (8) | 2 Participants |
| Tiotropium + Olodaterol FDC | General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later) | Visit 2_score (8) | 11 Participants |
Secondary
Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction
A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented.
Time frame: Visit 2 (approx. 6 weeks post baseline)
Population: FAS
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction | Very satisfied | 107 | 20 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction | Satisfied | 107 | 43 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction | Rather satisfied | 107 | 22 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction | Neither satisfied nor dissatisfied | 107 | 14 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction | Rather dissatisfied | 107 | 4 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction | Dissatisfied | 107 | 3 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction | Very dissatisfied | 107 | 1 Participants |
Secondary
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device
A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented.
Time frame: Visit 2 (approx. 6 weeks post baseline)
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device | Very satisfied | 33 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device | Satisfied | 45 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device | Rather satisfied | 14 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device | Neither satisfied nor dissatisfied | 9 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device | Rather dissatisfied | 5 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device | Dissatisfied | 1 Participants |
Secondary
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device
A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. Count of patients with divisions from very dissatisfied to very satisfied are presented.
Time frame: Visit 2 (approx. 6 weeks post baseline)
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device | Very satisfied | 25 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device | Satisfied | 45 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device | Rather satisfied | 20 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device | Neither satisfied nor dissatisfied | 10 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device | Rather dissatisfied | 5 Participants |
| Tiotropium + Olodaterol FDC | Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device | Dissatisfied | 2 Participants |