Trial Outcomes & Findings for Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice (NCT NCT02675517)

Last Updated: 2018-10-15

Results Overview

Therapeutic success defined as a minimum 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) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.

Recruitment status

COMPLETED

Target enrollment

1737 participants

Primary outcome timeframe

after approximately 6 weeks

Results posted on

2018-10-15

Participant Flow

1737 patients were treated. Of these 1578 patients had both visits documented as well as filled in all questionnaires, thus being evaluable for analysis of primary and secondary endpoints .

All subjects were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the subjects) met all implemented inclusion/exclusion criteria. Subjects were not to be entered to trial drug if any of the specific entry criteria was violated.

Participant milestones

Participant milestones
Measure	Spiolto Respimat COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Overall Study STARTED	1737
Overall Study COMPLETED	1578
Overall Study NOT COMPLETED	159

Reasons for withdrawal

Reasons for withdrawal
Measure	Spiolto Respimat COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Overall Study No evaluable PF-10 questionnaire at all	8
Overall Study Evaluable PF-10 questionnaire at visit1	151

Baseline Characteristics

Treated set

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spiolto Respimat n=1737 Participants COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Age, Continuous	66.51 Years STANDARD_DEVIATION 10.30 • n=1737 Participants • Treated set
Sex: Female, Male Female	747 Participants n=1737 Participants
Sex: Female, Male Male	990 Participants n=1737 Participants

PRIMARY outcome

Timeframe: after approximately 6 weeks

Population: Full analysis set (FAS): This analysis set consist of all screened patients with informed consent, date of registration, at least one documented administration of Spiolto® Respimat® \& available PF-10 score at visit 1\&2, \& confirmed main diagnosis of COPD in whom treatment with long-acting anticholinergics plus bronchodilators is indicated.

Outcome measures

Outcome measures
Measure	Spiolto Respimat n=1578 Participants COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).	51.52 Percentage of patients Interval 49.02 to 54.01

SECONDARY outcome

Timeframe: baseline and approx. week 6

Population: FAS

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).

Outcome measures

Outcome measures
Measure	Spiolto Respimat n=1578 Participants COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Changes in the PF-10 Score From Visit 1 to Visit 2	11.63 Unit on Scale Standard Deviation 19.04

SECONDARY outcome

Timeframe: Baseline (Visit 1) and Week 6 (approx.) (Visit 2)

Population: FAS

Physician's Global Evaluation (PGE) score documented by physicians at visit 1 (baseline) and at visit 2 (approx. 6 weeks later). the PGE score documented from 1 to 8. The highest value (=8) representing an excellent general condition

Outcome measures

Outcome measures
Measure	Spiolto Respimat n=1578 Participants COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Baseline (Visit 1) : PGE score 1	1.20 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Baseline (Visit 1) : PGE score 2	11.28 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Baseline (Visit 1) : PGE score 3	22.69 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Baseline (Visit 1) : PGE score 4	30.04 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Baseline (Visit 1) : PGE score 5	18.82 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Baseline (Visit 1) : PGE score 6	11.91 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Baseline (Visit 1) : PGE score 7	3.61 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Baseline (Visit 1) : PGE score 8	0.44 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Week 6 (approx.) (Visit 2): Score 1	0.25 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Week 6 (approx.) (Visit 2): Score 2	3.68 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Week 6 (approx.) (Visit 2): Score 3	10.71 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Week 6 (approx.) (Visit 2): Score 4	18.12 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Week 6 (approx.) (Visit 2): Score 5	28.33 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Week 6 (approx.) (Visit 2): Score 6	24.97 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Week 6 (approx.) (Visit 2): Score 7	11.98 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Week 6 (approx.) (Visit 2): Score 8	1.71 Percentage of participants
General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2. Week 6 (approx.) (Visit 2): missing	0.25 Percentage of participants

SECONDARY outcome

Timeframe: Week 6 (approx.) (Visit 2)

Population: FAS

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

Outcome measures

Outcome measures
Measure	Spiolto Respimat n=1578 Participants COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). Very satisfied	33.59 Percentage of participants
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). Satisfied	48.86 Percentage of participants
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). Rather satisfied	8.11 Percentage of participants
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). Neither satisfied nor dissatisfied	3.99 Percentage of participants
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). Rather dissatisfied	2.09 Percentage of participants
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). Dissatisfied	2.66 Percentage of participants
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). Very dissatisfied	0.63 Percentage of participants
Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2). Not answered	0.06 Percentage of participants

SECONDARY outcome

Timeframe: Week 6 (approx.) (Visit 2)

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

Outcome measures

Outcome measures
Measure	Spiolto Respimat n=1578 Participants COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). Very satisfied	35.17 percentage of participants
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). Satisfied	52.34 percentage of participants
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). Very dissatisfied	0.32 percentage of participants
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). Not answered	0.13 percentage of participants
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). Rather satisfied	6.91 percentage of participants
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). Neither satisfied nor dissatisfied	3.49 percentage of participants
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). Rather dissatisfied	0.89 percentage of participants
Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2). Dissatisfied	0.76 percentage of participants

SECONDARY outcome

Timeframe: Week 6 (approx.) (Visit 2)

Population: FAS

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

Outcome measures

Outcome measures
Measure	Spiolto Respimat n=1578 Participants COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). Very satisfied	33.08 percentage of participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). Satisfied	52.09 percentage of participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). Rather satisfied	9.82 percentage of participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). Neither satisfied nor dissatisfied	2.98 percentage of participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). Rather dissatisfied	0.82 percentage of participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). Dissatisfied	0.82 percentage of participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). Very dissatisfied	0.32 percentage of participants
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2). Not answered	0.06 percentage of participants

Adverse Events

Spiolto Respimat

Serious events: 3 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Spiolto Respimat n=1737 participants at risk COPD patients were administered 2.5 microgram/2.5 microgram per puff inhalation solution of the fixed combination therapy of two long-acting bronchodilators (Long-acting muscarinic antagonist (LAMA) + Long-acting beta2 adrenoceptor agonist (LABA)) via one device Respimat® for approximately 6 weeks according to approved Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines
Cardiac disorders Cardiac arrest	0.06% 1/1737 • From first drug administration until end of study, up to approx 6 weeks.
Cardiac disorders Cardiac failure	0.06% 1/1737 • From first drug administration until end of study, up to approx 6 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.06% 1/1737 • 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.
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