Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple... | NCT03954132

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Spiolto® Respimat®
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.	Drug: Triple-Therapy (LAMA/LABA/ICS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spiolto® Respimat®	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation	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.	Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).
Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment)	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.	Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks).

Secondary Outcomes

Measure	Description	Time Frame
Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline	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).	Baseline at Visit 1 (day 0)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients can be included if all of the following criteria are met:

Diagnosis of COPD
Symptomatic (with regard to dyspnea (mMRC Dyspnea score ≥1) AND with regard to symptoms (CAT Score ≥10) at the same time)
Patients on LABA/ICS maintenance therapy who are switched to Spiolto® Respimat® in the new reusable inhaler or a free/fixed triple combination of LABA + LAMA + ICS at Visit 1 at the discretion of the treating physician.
Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
Male or female
Patients aged ≥40 years of age
Written informed consent prior to study participation
The patient is willing and able to follow the procedures outlined in the protocol

Exclusion Criteria:

Patients with contraindications acc. to SmPC
Patients not on LABA/ICS maintenance treatment at visit 1, e.g., mono or dual bronchodilation only, ICS only, or a triple combination of LAMA + LABA + ICS (either as a fixed combination product or as separate components)
Lack of informed consent
Pregnant and/or lactating females
Acute exacerbation of COPD (within 4 weeks prior to Visit 1)
Frequently exacerbating patients, i. e. patients with ≥2 moderate exacerbations within the last 12 months or ≥1 exacerbation leading to hospitalization within the last 12 months
Acute respiratory failure (pH <7,35 and/ or respiratory rate >30/min within 3 months prior to Visit 1)
History or current diagnosis of asthma
History or current diagnosis of asthma-COPD overlap
History or current diagnosis of allergic rhinitis within the last 5 years
History or current diagnosis of lung cancer within the last 5 years
Participation in a parallel interventional clinical trial
mild exacerbation: additional use of short-acting bronchodilators and treated by the patient without consulting a physician
moderate exacerbation: treatment includes medical prescription of a systemic corticosteroid and/or antibiotic
severe exacerbation: exacerbation leading to hospitalization

Name	Affiliation	Role
Andrea Marseille, 0049613277141881	andrea.marseille@boehringer-ingelheim.com	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Graubner		Bad Sachsa		37441	Germany
Dr. Junggeburth

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37256536	Derived	Buhl R, Dreher M, Mattiucci-Guehlke M, Emerson-Stadler R, Eckhardt S, Taube C, Vogelmeier CF. EVELUT(R): A Real-World, Observational Study Assessing Dyspnoea and Symptom Burden in COPD Patients Switched from LABA/ICS to LAMA/LABA or LAMA/LABA/ICS. Adv Ther. 2023 Jul;40(7):3263-3278. doi: 10.1007/s12325-023-02524-y. Epub 2023 May 31.
33122898

Label	URL
Related Info	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 7, 2019	Aug 26, 2022

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

- ParticipantsBG000329
- ParticipantsBG001134
- ParticipantsBG002463

Title	Measurements

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG000329 ParticipantsBG001134 ParticipantsBG002

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

modified Medical Research Council (mMRC) score

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.

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.

Mean

Standard Deviation

Score on a scale

Title	Denominators	Categories
	ParticipantsBG000121 ParticipantsBG001

CATᵀᴹ (COPD assessment test) score

The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CATᵀᴹ). The CATᵀᴹ consists of eight items, each formatted as a semantic six-point differential scale. 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.

Mean

Standard Deviation

Score on a scale

Title	Denominators	Categories
	ParticipantsBG000121 ParticipantsBG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation

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.

Posted

Mean

95% Confidence Interval

Change in score on a scale

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

ID	Title	Description
OG000	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)	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.
OG001	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)	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.

Units	Counts
Participants	OG000111 OG001118

Title

Denominators

Categories

Title	Measurements
	OG0000.23(0.11 to 0.36) OG0010.25(0.13 to 0.38)

Primary

Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment)

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.

Posted

Mean

95% Confidence Interval

Change in score on a scale

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

ID	Title	Description
OG000	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)	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.

Secondary

Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline

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).

Posted

Count of Participants

Participants

Baseline at Visit 1 (day 0)

ID	Title	Description
OG000	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)	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.
OG001	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)

Secondary

Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period

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).

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)	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.
OG001	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)

Secondary

Patient Satisfaction With Inhaler and Therapy at End of Observation Period

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).

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)	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.
OG001	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)

Secondary

Number of Responders With Δ mMRC≥ 1

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).

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)	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.
OG001	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)

Secondary

Number of Responders With Δ CAT≥ 2

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)	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.
OG001	Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto)

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	329	1	329	0	329
EG001	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.	0	134	0	134	0	134

Certain Agreements

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.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms