Trial Outcomes & Findings for Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®) (NCT NCT03954132)

Last Updated: 2024-04-24

Results Overview

Change in mMRC (modified Medical Research Council) score between baseline and after end of observation (ca. 12 weeks of treatment, Visit 2). The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea, where a 0 is the best possible score with no disability and 4 is the worst possible score representing the most severity. The mMRC will be used to assess the breathlessness state of the patient with just one question: "When do you experience dyspnoea?", covering five everyday activities, potentially leading to dyspnoea and giving an according rate of 0 to 4 points. The Minimum Clinically Important Difference (MCID) is a change of 1.0 point. Change calculated as Visit 1 - Visit 2.

Recruitment status

COMPLETED

Target enrollment

469 participants

Primary outcome timeframe

Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

Results posted on

2024-04-24

Participant Flow

This was an open-label comparative multicentric cohort non interventional study based on newly collected data. Chronic Obstructive Pulmonary Disease (COPD) patients receiving a Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids treatment until visit 1 were switched at the discretion of the attending physician to either tiotropium/olodaterol in the new reusable Respimat® inhaler or any triple therapy according to clinical routine. Observational period was approximately 12 weeks.

All patients were screened for eligibility prior to participation in the trial. 6 patients were not recruited and treated. 24 patients in the treated set had at least one violations of the in- and/or exclusion criteria and were not included in the per protocol set (and the derived matched set).

Participant milestones

Participant milestones
Measure	Spiolto® Respimat® Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.	Triple-Therapy (LAMA/LABA/ICS) Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.
Overall Study STARTED	329	134
Overall Study Per Protocol Set	309	129
Overall Study Treated Subjects With Protocol Violations	19	5
Overall Study Treated Subjects Excluded From Per Protocol Set	1	0
Overall Study COMPLETED	303	129
Overall Study NOT COMPLETED	26	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Spiolto® Respimat® Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.	Triple-Therapy (LAMA/LABA/ICS) Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.
Overall Study Adverse Event	2	0
Overall Study Patient's wish	5	0
Overall Study Lost to Follow-up	10	0
Overall Study Screening failure	0	1
Overall Study No registration after Visit 1	5	2
Overall Study Other reason than listed	2	2
Overall Study Patient could not make visit due to vertebral fracture	1	0
Overall Study False inclusion, violation of exclusion criteria	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spiolto® Respimat® n=329 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.	Triple-Therapy (LAMA/LABA/ICS) n=134 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.	Total n=463 Participants Total of all reporting groups
Age, Continuous	66.5 years STANDARD_DEVIATION 10.7 • n=329 Participants	69.2 years STANDARD_DEVIATION 8.9 • n=134 Participants	67.3 years STANDARD_DEVIATION 10.3 • n=463 Participants
Sex: Female, Male Female	159 Participants n=329 Participants	56 Participants n=134 Participants	215 Participants n=463 Participants
Sex: Female, Male Male	170 Participants n=329 Participants	78 Participants n=134 Participants	248 Participants n=463 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
modified Medical Research Council (mMRC) score	2.07 Score on a scale STANDARD_DEVIATION 0.80 • n=121 Participants • Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data were not replaced or imputed.	2.07 Score on a scale STANDARD_DEVIATION 0.81 • n=121 Participants • Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data were not replaced or imputed.	2.07 Score on a scale STANDARD_DEVIATION 0.80 • n=242 Participants • Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data were not replaced or imputed.
CATᵀᴹ (COPD assessment test) score	21.72 Score on a scale STANDARD_DEVIATION 6.29 • n=121 Participants • Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data were not replaced or imputed.	21.79 Score on a scale STANDARD_DEVIATION 6.72 • n=121 Participants • Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data were not replaced or imputed.	21.76 Score on a scale STANDARD_DEVIATION 6.49 • n=242 Participants • Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data were not replaced or imputed.

PRIMARY outcome

Timeframe: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

Population: Matched set (MS): All patients with informed consent who met all inclusion criteria as well as no exclusion criteria and have received at least one dose of Spiolto® Respimat® or triple combination (free or fixed LAMA + LABA+ ICS), excluding all patients who could not be matched in the propensity score matching, patients with missing data for this outcome measure were not replaced or imputed.

Outcome measures

Outcome measures
Measure	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=111 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=118 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.
Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation	0.23 Change in score on a scale Interval 0.11 to 0.36	0.25 Change in score on a scale Interval 0.13 to 0.38

PRIMARY outcome

Timeframe: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CATᵀᴹ) was developed as a simple instrument to assess health status in patients with COPD. The CATᵀᴹ consists of eight items, each formatted as a semantic six-point differential scale, making the tool easy to administer and easy for patients to complete. These eight items cover cough, phlegm, chest tightness, breathlessness when going up hills/stairs, activity limitations at home, confidence leaving home, sleep and energy. Each item is scored from 0 to 5. Total CAT score is calculated as the sum over the 8 items, resulting in a total score ranging from 0 to 40, corresponding to the best and worst health status in patients with COPD, respectively. The Minimum Clinically Important Difference (MCID) is a change of 2.0 points. Change is calculated as Visit 1 - Visit 2.

Outcome measures

Outcome measures
Measure	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=111 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=118 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.
Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment)	3.45 Change in score on a scale Interval 2.45 to 4.45	2.51 Change in score on a scale Interval 1.62 to 3.4

SECONDARY outcome

Timeframe: Baseline at Visit 1 (day 0)

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 1-2 (poor), 3-4 (satisfactory), 5-6 (good) to 7-8 (excellent).

Outcome measures

Outcome measures
Measure	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=121 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=121 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline PGE score 1	0 Participants	0 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline PGE score 2	3 Participants	4 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline PGE score 3	17 Participants	26 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline PGE score 4	48 Participants	49 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline PGE score 5	27 Participants	26 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline PGE score 6	20 Participants	12 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline PGE score 7	4 Participants	3 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline PGE score 8	1 Participants	0 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline Missing	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Visit 2 (planned at 12 week, up to a maximum of 42 weeks)

The treating physician will use 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).

Outcome measures

Outcome measures
Measure	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=112 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=119 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period PGE score 1	0 Participants	1 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period PGE score 2	3 Participants	3 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period PGE score 3	9 Participants	18 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period PGE score 4	27 Participants	31 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period PGE score 5	26 Participants	25 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period PGE score 6	34 Participants	28 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period PGE score 7	12 Participants	9 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period PGE score 8	1 Participants	2 Participants
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period Missing	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

Patient satisfaction with inhaler and therapy at end of observation period according to a seven-point ordinal scale (ranging from very dissatisfied to very satisfied).

Outcome measures

Outcome measures
Measure	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=112 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=55 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with handling of the inhalation device · Very satisfied	27 Participants	17 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient overall satisfaction with treatment · Very satisfied	31 Participants	17 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient overall satisfaction with treatment · Satisfied	58 Participants	21 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient overall satisfaction with treatment · Rather satisfied	7 Participants	7 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient overall satisfaction with treatment · Neither satisfied nor dissatisfied	7 Participants	4 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient overall satisfaction with treatment · Rather dissatisfied	4 Participants	2 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient overall satisfaction with treatment · Dissatisfied	1 Participants	0 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient overall satisfaction with treatment · Very dissatisfied	3 Participants	1 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient overall satisfaction with treatment · Missing	1 Participants	3 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with handling of the inhalation device · Satisfied	66 Participants	26 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with handling of the inhalation device · Rather satisfied	11 Participants	5 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with handling of the inhalation device · Neither satisfied nor dissatisfied	5 Participants	3 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with handling of the inhalation device · Rather dissatisfied	2 Participants	0 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with handling of the inhalation device · Dissatisfied	0 Participants	0 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with handling of the inhalation device · Very dissatisfied	0 Participants	0 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with handling of the inhalation device · Missing	1 Participants	4 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with inhaling from the device · Very satisfied	31 Participants	20 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with inhaling from the device · Satisfied	63 Participants	22 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with inhaling from the device · Rather satisfied	8 Participants	6 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with inhaling from the device · Neither satisfied nor dissatisfied	7 Participants	3 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with inhaling from the device · Rather dissatisfied	2 Participants	0 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with inhaling from the device · Dissatisfied	0 Participants	0 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with inhaling from the device · Very dissatisfied	0 Participants	0 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with inhaling from the device · Missing	1 Participants	4 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with the device in general · Very satisfied	30 Participants	16 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with the device in general · Satisfied	65 Participants	26 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with the device in general · Rather satisfied	9 Participants	4 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with the device in general · Neither satisfied nor dissatisfied	4 Participants	4 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with the device in general · Rather dissatisfied	2 Participants	1 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with the device in general · Dissatisfied	0 Participants	0 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with the device in general · Very dissatisfied	1 Participants	0 Participants
Patient Satisfaction With Inhaler and Therapy at End of Observation Period Patient satisfaction with the device in general · Missing	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

Number of responders with a change in modified Medical Research Council (mMRC) greater than or equal to 1 between visit 1 and 2. The mMRC was used to assess the severity of the breathlessness. the mMRC consists of five statements describing the patients grade of breathlessness ranging from 0 (best outcome) to 4 (worst outcome).

Outcome measures

Outcome measures
Measure	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=112 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=119 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.
Number of Responders With Δ mMRC≥ 1 Δ mMRC<1	83 Participants	92 Participants
Number of Responders With Δ mMRC≥ 1 Δ mMRC≥1	28 Participants	26 Participants
Number of Responders With Δ mMRC≥ 1 Not available	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

Number of responders with a change in the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) greater than or equal to 2 between visit 1 and 2.

Outcome measures

Outcome measures
Measure	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=112 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting. Patients were propensity score matched to the Triple-Therapy arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) n=119 Participants Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting. Patients were propensity score matched to the Spiolto® Respimat® arm, propensity score was calculated based on a logistic regression model taking the choice of treatment as dependent variable and baseline characteristics as independent variables into account.
Number of Responders With Δ CAT≥ 2 Δ CAT<2	35 Participants	51 Participants
Number of Responders With Δ CAT≥ 2 Δ CAT≥2	76 Participants	67 Participants
Number of Responders With Δ CAT≥ 2 Not available	1 Participants	1 Participants

Adverse Events

Spiolto® Respimat®

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Triple-Therapy (LAMA/LABA/ICS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Spiolto® Respimat® n=329 participants at risk Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to Spiolto® Respimat® inhaler by their attending physician in an real-world setting.	Triple-Therapy (LAMA/LABA/ICS) n=134 participants at risk Chronic Obstructive Pulmonary Disease (COPD) patients who were symptomatic (dyspneic) despite Long-acting beta2 adrenoceptor agonist/Inhalative Corticosteroids (LABA/ICS) maintenance treatment were switched to any triple therapy Long-acting muscarinic antagonist + Long-acting beta2 adrenoceptor agonist + Inhalative Corticosteroids (LAMA + LABA + ICS) by their attending physician in an real-world setting.
Vascular disorders Hypertension	0.30% 1/329 • The study design is of non-interventional nature and the study is conducted within the conditions of the approved marketing authorization. Sufficient data from controlled interventional trials are available to support the evidence on the safety and efficacy of the studied BI drug. Collected were: - all adverse drug reaction (ADRs) (serious and non-serious), - all adverse events with fatal outcome From the beginning of treatment till the end of the study, up to 42 weeks.	0.00% 0/134 • The study design is of non-interventional nature and the study is conducted within the conditions of the approved marketing authorization. Sufficient data from controlled interventional trials are available to support the evidence on the safety and efficacy of the studied BI drug. Collected were: - all adverse drug reaction (ADRs) (serious and non-serious), - all adverse events with fatal outcome From the beginning of treatment till the end of the study, up to 42 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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