Trial Outcomes & Findings for Assessment of Physical Functioning and Handling of Spiolto Respimat in Patients With COPD (OTIVACTO) (NCT NCT02720757)
NCT ID: NCT02720757
Last Updated: 2019-04-16
Results Overview
"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
TERMINATED
132 participants
Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)
2019-04-16
Participant Flow
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).
Patients were enrolled consecutively and were followed over an observational period of approximately 6 weeks, which was the average time between two medical consultations
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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132
|
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Overall Study
COMPLETED
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114
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Overall Study
NOT COMPLETED
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18
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Reasons for withdrawal
| Measure |
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
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|---|---|
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Overall Study
Other reason
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5
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Overall Study
Loss of contact
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4
|
|
Overall Study
Informed consent withdrawal
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1
|
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Overall Study
Patients wish to withdraw
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2
|
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Overall Study
Missing
|
3
|
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Overall Study
General exclusion
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3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tiotropium + Olodaterol FDC
n=127 Participants
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
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|---|---|
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Age, Continuous
|
68.81 years
STANDARD_DEVIATION 9.39 • n=127 Participants
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|
Sex: Female, Male
Female
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78 Participants
n=127 Participants
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Sex: Female, Male
Male
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49 Participants
n=127 Participants
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PRIMARY outcome
Timeframe: 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
"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
Outcome measures
| Measure |
Tiotropium + Olodaterol FDC
n=107 Participants
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
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|---|---|
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Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline
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44.90 percentage of participants
Interval 32.23 to 54.78
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SECONDARY outcome
Timeframe: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)Population: FAS
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.
Outcome measures
| Measure |
Tiotropium + Olodaterol FDC
n=107 Participants
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
|
|---|---|
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Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)
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7.64 scores on a scale
Standard Deviation 17.60
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SECONDARY outcome
Timeframe: Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)Population: FAS
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.
Outcome measures
| Measure |
Tiotropium + Olodaterol FDC
n=107 Participants
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
|
|---|---|
|
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)
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7 Participants
|
|
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)
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1 Participants
|
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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)
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18 Participants
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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)
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14 Participants
|
|
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)
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28 Participants
|
|
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)
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14 Participants
|
|
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)
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18 Participants
|
|
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)
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14 Participants
|
|
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
|
|
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
|
|
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)
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15 Participants
|
|
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)
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20 Participants
|
|
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)
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2 Participants
|
|
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)
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11 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (approx. 6 weeks post baseline)Population: FAS
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.
Outcome measures
| Measure |
Tiotropium + Olodaterol FDC
n=107 Participants
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
|
|---|---|
|
Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction
Very satisfied · 107
|
20 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction
Satisfied · 107
|
43 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction
Rather satisfied · 107
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22 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction
Neither satisfied nor dissatisfied · 107
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14 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction
Rather dissatisfied · 107
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4 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction
Dissatisfied · 107
|
3 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction
Very dissatisfied · 107
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (approx. 6 weeks post baseline)Population: FAS
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.
Outcome measures
| Measure |
Tiotropium + Olodaterol FDC
n=107 Participants
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
|
|---|---|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device
Very satisfied
|
25 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device
Satisfied
|
45 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device
Rather satisfied
|
20 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device
Neither satisfied nor dissatisfied
|
10 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device
Rather dissatisfied
|
5 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device
Dissatisfied
|
2 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (approx. 6 weeks post baseline)Population: FAS
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.
Outcome measures
| Measure |
Tiotropium + Olodaterol FDC
n=107 Participants
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
|
|---|---|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device
Very satisfied
|
33 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device
Satisfied
|
45 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device
Rather satisfied
|
14 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device
Neither satisfied nor dissatisfied
|
9 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device
Rather dissatisfied
|
5 Participants
|
|
Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device
Dissatisfied
|
1 Participants
|
Adverse Events
Tiotropium + Olodaterol FDC
Serious adverse events
Adverse event data not reported
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