Trial Outcomes & Findings for OTIVACTO Spain Non Interventional Study (NCT NCT02927795)

Last Updated: 2019-09-30

Results Overview

Therapeutic success defined as at least 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 subdomain of the validated Short Form 36 (SF-36 ) and 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 sum of the scores of the 10 questions results 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 was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20. Higher scores indicate better physical functioning.

Recruitment status

COMPLETED

Target enrollment

257 participants

Primary outcome timeframe

After approximately 6 weeks (visit 2)

Results posted on

2019-09-30

Participant Flow

Open-label observational study, including Chronic Obstructive Pulmonary Disease (COPD) patients in Spain receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations. Questionnaire (quest.). 10-point increase of Physical functioning questionnaire (PF10 )

All participants were screened for eligibility to participate in the study. Participants attended primary care centres which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered if any one of the specific entry criteria were not met.

Participant milestones

Participant milestones
Measure	Spiolto® Respimat® Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Overall Study STARTED	257
Overall Study Treated	253
Overall Study COMPLETED	234
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Spiolto® Respimat® Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Overall Study Non-evaluable PF10 quest. at visit 2	19
Overall Study Not Treated	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spiolto® Respimat® n=253 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Age, Continuous	68.41 Years STANDARD_DEVIATION 10.83 • n=253 Participants
Sex: Female, Male Female	68 Participants n=253 Participants
Sex: Female, Male Male	185 Participants n=253 Participants

PRIMARY outcome

Timeframe: After approximately 6 weeks (visit 2)

Population: Full Analysis Set (FAS): All screened patients with at least one documented administration of Spiolto® Respimat® and available PF-10 score at visit 1 and visit 2.

Outcome measures

Outcome measures
Measure	Spiolto® Respimat® n=234 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)	66.2 Percentage of Patients (%) Interval 60.2 to 72.3

SECONDARY outcome

Timeframe: Baseline (visit 1) and after approx. week 6 (visit 2)

Population: FAS

The change in Physical functioning questionnaire (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) and then the mean for change from baseline values across all patients was calculated. The PF-10 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 sum of the scores of the 10 questions results 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 was standardized to a range of 0 to 100 using the following formula: \[(sum of scale items - 10) \* 100\] / 20. Higher scores indicate better physical functioning.

Outcome measures

Outcome measures
Measure	Spiolto® Respimat® n=234 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2	16.04 Unit on scale Standard Deviation 18.18

SECONDARY outcome

Timeframe: Baseline (visit 1) and after approx.week 6 (visit 2)

Population: FAS

The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent

Outcome measures

Outcome measures
Measure	Spiolto® Respimat® n=234 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 1	2 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 2	48 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 3	57 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 4	49 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 5	35 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 6	31 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 7	7 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 8	5 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 1	1 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 2	5 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 3	14 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 4	42 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 5	46 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 6	83 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 7	36 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 8	7 Participants

SECONDARY outcome

Timeframe: After approx. 6 weeks (visit 2) of treatment initiation

Population: FAS who completed the questionnaire.14 patients with missing data were excluded from the analysis.

A patient satisfaction questionnaire on how overall satisfied they were with the Spiolto® Respimat® treatment was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).

Outcome measures

Outcome measures
Measure	Spiolto® Respimat® n=220 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 Very unsatisfied	0 Participants
Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 Unsatisfied	2 Participants
Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 Rather unsatisfied	6 Participants
Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 Neither satisfied, nor unsatisfied	15 Participants
Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 Rather satisfied	27 Participants
Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 Satisfied	127 Participants
Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2 Very satisfied	43 Participants

SECONDARY outcome

Timeframe: After approx. 6 weeks (visit 2) of treatment initiation

Population: FAS

A patient satisfaction questionnaire on how satisfied they were by inhaling with the Respimat® device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).

Outcome measures

Outcome measures
Measure	Spiolto® Respimat® n=234 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Patient Satisfaction With Inhaling From the Respimat® Device Very unsatisfied	1 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Unsatisfied	3 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Rather unsatisfied	2 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Neither satisfied, nor unsatisfied	16 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Rather satisfied	25 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Satisfied	129 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Very satisfied	58 Participants

SECONDARY outcome

Timeframe: After approx. 6 weeks (visit 2) of treatment initiation

Population: FAS

A patient satisfaction questionnaire on how satisfied they were with handling of the Respimat® inhalation device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).

Outcome measures

Outcome measures
Measure	Spiolto® Respimat® n=234 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Patient Satisfaction With Handling of the Respimat® Inhalation Device Very unsatisfied	0 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Unsatisfied	2 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Rather unsatisfied	4 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Neither satisfied, nor unsatisfied	14 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Rather satisfied	29 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Satisfied	132 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Very satisfied	53 Participants

Adverse Events

Spiolto® Respimat®

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Spiolto® Respimat® n=253 participants at risk Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium and olodaterol in a fixed dose combination through a single Respimat® inhalation device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Vascular disorders Ischaemic stroke	0.40% 1/253 • From first drug administration until end of study, up to approx 6 weeks.

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER