Trial Outcomes & Findings for Effectiveness and Handling of Spiolto® Respimat ® in COPD Patients - Italy (NCT NCT03003494)

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 sub-domain 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

306 participants

Primary outcome timeframe

after approximately 6 weeks

Results posted on

2019-09-30

Participant Flow

Patient with chronic Obstructive Pulmonary Disease receiving treatment Spiolto® Respimat® were enrolled between July 2017 and May 2018. 309 screened and 3 patient violated inclusion/exclusion criteria were excluded, 306 entered the trial

All participants were screened for eligibility to participate in the study. Participants attended specialist sites 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. Physical Functioning patient questionnaire (PF10)

Participant milestones

Participant milestones
Measure	Spiolto Respimat Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Overall Study STARTED	306
Overall Study COMPLETED	278
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Spiolto Respimat Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Overall Study Evaluable PF10 questionnaire at visit1	28

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spiolto Respimat n=306 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Age, Continuous	71.04 Years STANDARD_DEVIATION 8.81 • n=306 Participants
Sex: Female, Male Female	90 Participants n=306 Participants
Sex: Female, Male Male	216 Participants n=306 Participants

PRIMARY outcome

Timeframe: after approximately 6 weeks

Population: Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed PF-10 questionnaire at both study visits.

Outcome measures

Outcome measures
Measure	Spiolto Respimat n=278 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat 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)	52.52 Percentage of Participants (%) Interval 46.47 to 58.51

SECONDARY outcome

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

Population: FAS

The change in 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 median for change from baseline values across all subjects was calculated.

Outcome measures

Outcome measures
Measure	Spiolto Respimat n=278 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2	10 Unit on scale Interval -60.0 to 80.0

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=278 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat 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	5 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 3	69 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 4	72 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 5	65 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 6	46 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 7	19 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Baseline (Visit 1) : PGE score 8	0 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 1	0 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 2	2 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 3	18 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 4	32 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 5	65 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 6	113 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 7	42 Participants
Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2 Week 6 (approx.) (Visit 2): Score 8	6 Participants

SECONDARY outcome

Timeframe: After approx. 6 weeks of treatment initiation

Population: FAS

Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2).

Outcome measures

Outcome measures
Measure	Spiolto Respimat n=278 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat 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® Very satisfied	31 Participants
Patient Overall Satisfaction With Spiolto® Respimat® Satisfied	111 Participants
Patient Overall Satisfaction With Spiolto® Respimat® Rather satisfied	98 Participants
Patient Overall Satisfaction With Spiolto® Respimat® Neither satisfied nor dissatisfied	29 Participants
Patient Overall Satisfaction With Spiolto® Respimat® Rather dissatisfied	5 Participants
Patient Overall Satisfaction With Spiolto® Respimat® Dissatisfied	0 Participants
Patient Overall Satisfaction With Spiolto® Respimat® Very dissatisfied	2 Participants
Patient Overall Satisfaction With Spiolto® Respimat® Questionnaire not completed	2 Participants

SECONDARY outcome

Timeframe: After approx. 6 weeks of treatment initiation

Population: FAS

Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2)

Outcome measures

Outcome measures
Measure	Spiolto Respimat n=278 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat 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 satisfied	47 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Satisfied	119 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Rather satisfied	83 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Neither satisfied nor dissatisfied	23 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Rather dissatisfied	2 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Dissatisfied	1 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Very dissatisfied	1 Participants
Patient Satisfaction With Inhaling From the Respimat® Device Questionnaire not completed	2 Participants

SECONDARY outcome

Timeframe: After approx. 6 weeks of treatment initiation

Population: FAS

Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2).

Outcome measures

Outcome measures
Measure	Spiolto Respimat n=278 Participants Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat 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 satisfied	57 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Satisfied	121 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Rather satisfied	70 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Neither satisfied nor dissatisfied	19 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Rather dissatisfied	4 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Dissatisfied	5 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Very dissatisfied	0 Participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device Questionnaire not completed	2 Participants

Adverse Events

Spiolto Respimat

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Spiolto Respimat n=306 participants at risk Chronic Obstructive Pulmonary Disease (COPD) patients were administered a combination of tiotropium, an anticholinergic and olodaterol, a long-acting beta2-adrenergic agonist (LABA) in a Fixed dose combination through Respimat device according to approved Summary of Product Characteristics (SPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
General disorders Death	0.33% 1/306 • From first drug administration until end of study, up to approx 6 weeks. All safety analyses were based on the TS
Vascular disorders Hypertension	0.33% 1/306 • From first drug administration until end of study, up to approx 6 weeks. All safety analyses were based on the TS

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
Publication restrictions are in place