Trial Outcomes & Findings for OTIVACTO Regional Center Vienna (RCV) Non-Interventional Study (NIS) (NCT NCT02719639)
NCT ID: NCT02719639
Last Updated: 2019-01-09
Results Overview
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.
COMPLETED
7443 participants
Approximately 6 weeks
2019-01-09
Participant Flow
This is an open label observational study in Chronic Obstructive Pulmonary Disease (COPD) patients from 534 investigational sites in 9 countries.
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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7443
|
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Overall Study
COMPLETED
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7443
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treated set (TS): All patients enrolled, registered and received at least one dose were included in the treated set.
Baseline characteristics by cohort
| Measure |
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
n=7443 Participants
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.
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|---|---|
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Age, Continuous
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65.07 Years
STANDARD_DEVIATION 9.33 • n=7443 Participants • Treated set (TS): All patients enrolled, registered and received at least one dose were included in the treated set.
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Sex: Female, Male
Female
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2349 Participants
n=7443 Participants • Treated set (TS): All patients enrolled, registered and received at least one dose were included in the treated set.
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Sex: Female, Male
Male
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5094 Participants
n=7443 Participants • Treated set (TS): All patients enrolled, registered and received at least one dose were included in the treated set.
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PRIMARY outcome
Timeframe: Approximately 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
n=7218 Participants
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.
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Percentage of Patients With Therapeutic Success After Approximately 6 Weeks.
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67.76 Percentage of participants (%)
Interval 66.67 to 68.84
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SECONDARY outcome
Timeframe: Baseline and week 6Population: 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.
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.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
n=7218 Participants
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.
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|---|---|
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Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2)
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16.62 Score on scale
Standard Deviation 17.87
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SECONDARY outcome
Timeframe: Baseline and week 6Population: 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.
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.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
n=7218 Participants
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.
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|---|---|
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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
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96 Participants
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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
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754 Participants
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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
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1907 Participants
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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
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2159 Participants
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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
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1317 Participants
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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
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743 Participants
|
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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
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203 Participants
|
|
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
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39 Participants
|
|
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
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0 Participants
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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
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53 Participants
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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
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261 Participants
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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
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887 Participants
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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
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1772 Participants
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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
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2458 Participants
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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
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1451 Participants
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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
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335 Participants
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SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
n=7218 Participants
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.
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|---|---|
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Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Very satisfied
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2847 Participants
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Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Satisfied
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2998 Participants
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Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Rather satisfied
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890 Participants
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Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Neither satisfied nor dissatisfied
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307 Participants
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Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Rather dissatisfied
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93 Participants
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Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Dissatisfied
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52 Participants
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Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Very dissatisfied
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26 Participants
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Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Not answered
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5 Participants
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SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
n=7218 Participants
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.
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|---|---|
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Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Very satisfied
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3143 Participants
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Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Satisfied
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3021 Participants
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Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Rather satisfied
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716 Participants
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Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Neither satisfied nor dissatisfied
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228 Participants
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Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Rather dissatisfied
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48 Participants
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Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Dissatisfied
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34 Participants
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|
Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Very dissatisfied
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11 Participants
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|
Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Not answered
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17 Participants
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SECONDARY outcome
Timeframe: Approximately 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
n=7218 Participants
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.
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|---|---|
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Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Very satisfied
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3086 Participants
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Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Satisfied
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2988 Participants
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|
Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Rather satisfied
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794 Participants
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Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Neither satisfied nor dissatisfied
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239 Participants
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|
Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Rather dissatisfied
|
55 Participants
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|
Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Dissatisfied
|
30 Participants
|
|
Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Very dissatisfied
|
9 Participants
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|
Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)
Not answered
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17 Participants
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Adverse Events
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
Serious adverse events
| Measure |
Spiolto® Respimat® 2.5 Microgram/ 2.5 Microgram
n=7443 participants at risk
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.
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|---|---|
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Cardiac disorders
Atrial fibrillation
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0.01%
1/7443 • From first dose adminstration until 21 days after permanently discontinuation of therapy or end of the study.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Analysis of adverse events were done on Treated set, which includes all patients enrolled, registered and received at least one dose.
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Infections and infestations
Pneumonia
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0.01%
1/7443 • From first dose adminstration until 21 days after permanently discontinuation of therapy or end of the study.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Analysis of adverse events were done on Treated set, which includes all patients enrolled, registered and received at least one dose.
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Infections and infestations
Sepsis
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0.01%
1/7443 • From first dose adminstration until 21 days after permanently discontinuation of therapy or end of the study.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Analysis of adverse events were done on Treated set, which includes all patients enrolled, registered and received at least one dose.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
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0.01%
1/7443 • From first dose adminstration until 21 days after permanently discontinuation of therapy or end of the study.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Analysis of adverse events were done on Treated set, which includes all patients enrolled, registered and received at least one dose.
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|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
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0.01%
1/7443 • From first dose adminstration until 21 days after permanently discontinuation of therapy or end of the study.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Analysis of adverse events were done on Treated set, which includes all patients enrolled, registered and received at least one dose.
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Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place