Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
Open-label comparative multicentric cohort study in COPD patients with LABA/ICS, switched to either tiotropium/olodaterol and observed for 12 weeks approximately.
Detailed description
COPD patients on LABA/ICS maintenance therapy with dyspnea (mMRC ≥ 1) and other symptoms (CATTM ≥ 10), who are switched to either Spiolto® Respimat® in the new reusable inhaler or any triple therapy (LAMA + LABA + ICS) as an open or fixed combination according to approved SmPCs at baseline at the discretion of their attending physician.
Interventions
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.
DRUGTriple-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.
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation | Baseline at Visit 1 (day 0) and Visit 2 (planned at 12 week, up to a maximum of 42 weeks). | 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. |
| Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Inhaler and Therapy at End of Observation Period | 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). |
| Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | 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). |
| Number of Responders With Δ CAT≥ 2 | 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. |
| Number of Responders With Δ mMRC≥ 1 | 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). |
| Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | 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). |
Countries
Germany
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 329 |
| 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. | 134 |
| Total | 463 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | False inclusion, violation of exclusion criteria | 1 | 0 |
| Overall Study | Lost to Follow-up | 10 | 0 |
| 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 | Patient's wish | 5 | 0 |
| Overall Study | Screening failure | 0 | 1 |
Baseline characteristics
| Characteristic | Spiolto® Respimat® | Triple-Therapy (LAMA/LABA/ICS) | Total |
|---|---|---|---|
| Age, Continuous | 66.5 years STANDARD_DEVIATION 10.7 | 69.2 years STANDARD_DEVIATION 8.9 | 67.3 years STANDARD_DEVIATION 10.3 |
| CATᵀᴹ (COPD assessment test) score | 21.72 Score on a scale STANDARD_DEVIATION 6.29 | 21.79 Score on a scale STANDARD_DEVIATION 6.72 | 21.76 Score on a scale STANDARD_DEVIATION 6.49 |
| modified Medical Research Council (mMRC) score | 2.07 Score on a scale STANDARD_DEVIATION 0.8 | 2.07 Score on a scale STANDARD_DEVIATION 0.81 | 2.07 Score on a scale STANDARD_DEVIATION 0.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 159 Participants | 56 Participants | 215 Participants |
| Sex: Female, Male Male | 170 Participants | 78 Participants | 248 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 329 | 0 / 134 |
| other Total, other adverse events | 0 / 329 | 0 / 134 |
| serious Total, serious adverse events | 1 / 329 | 0 / 134 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | 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 |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Change in CATᵀᴹ (COPD Assessment Test) Score Between Baseline and After End of Observation (ca. 12 Weeks of Treatment) | 2.51 Change in score on a scale |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation | 0.23 Change in score on a scale |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Change in Modified Medical Research Council (mMRC) Score Between Baseline and After End of Observation | 0.25 Change in score on a scale |
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ CAT≥ 2 | Δ CAT<2 | 35 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ CAT≥ 2 | Δ CAT≥2 | 76 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ CAT≥ 2 | Not available | 1 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ CAT≥ 2 | Δ CAT<2 | 51 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ CAT≥ 2 | Δ CAT≥2 | 67 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ CAT≥ 2 | Not available | 1 Participants |
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).
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ mMRC≥ 1 | Δ mMRC<1 | 83 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ mMRC≥ 1 | Δ mMRC≥1 | 28 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ mMRC≥ 1 | Not available | 1 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ mMRC≥ 1 | Δ mMRC<1 | 92 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ mMRC≥ 1 | Δ mMRC≥1 | 26 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Number of Responders With Δ mMRC≥ 1 | Not available | 1 Participants |
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).
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Very satisfied | 31 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Very satisfied | 27 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Satisfied | 63 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Rather dissatisfied | 4 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Rather satisfied | 8 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Satisfied | 66 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Neither satisfied nor dissatisfied | 7 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Rather satisfied | 7 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Rather dissatisfied | 2 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Dissatisfied | 1 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Dissatisfied | 0 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | 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 |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Very dissatisfied | 0 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Satisfied | 58 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Missing | 1 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Rather dissatisfied | 2 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Very satisfied | 30 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Very dissatisfied | 3 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Satisfied | 65 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Dissatisfied | 0 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Rather satisfied | 9 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Neither satisfied nor dissatisfied | 7 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Neither satisfied nor dissatisfied | 4 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Very dissatisfied | 0 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Rather dissatisfied | 2 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Missing | 1 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Dissatisfied | 0 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Missing | 1 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Very dissatisfied | 1 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Very satisfied | 31 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Missing | 1 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Rather satisfied | 11 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Missing | 4 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Very satisfied | 17 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Satisfied | 21 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Rather satisfied | 7 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Neither satisfied nor dissatisfied | 4 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Rather dissatisfied | 2 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Dissatisfied | 0 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Very dissatisfied | 1 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient overall satisfaction with treatment | Missing | 3 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Very satisfied | 17 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Satisfied | 26 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Rather satisfied | 5 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Neither satisfied nor dissatisfied | 3 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Rather dissatisfied | 0 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Dissatisfied | 0 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Very dissatisfied | 0 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with handling of the inhalation device | Missing | 4 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Very satisfied | 20 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Satisfied | 22 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Rather satisfied | 6 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Neither satisfied nor dissatisfied | 3 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Rather dissatisfied | 0 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Dissatisfied | 0 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Very dissatisfied | 0 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with inhaling from the device | Missing | 4 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Very satisfied | 16 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Satisfied | 26 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Rather satisfied | 4 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Neither satisfied nor dissatisfied | 4 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Rather dissatisfied | 1 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Dissatisfied | 0 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patient Satisfaction With Inhaler and Therapy at End of Observation Period | Patient satisfaction with the device in general | Very dissatisfied | 0 Participants |
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).
Time frame: Baseline at Visit 1 (day 0)
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 2 | 3 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 6 | 20 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 4 | 48 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 7 | 4 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 3 | 17 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 8 | 1 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 5 | 27 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | Missing | 1 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 1 | 0 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | Missing | 1 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 1 | 0 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 2 | 4 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 3 | 26 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 4 | 49 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 5 | 26 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 6 | 12 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 7 | 3 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at Baseline | PGE score 8 | 0 Participants |
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).
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 2 | 3 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 6 | 34 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 4 | 27 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 7 | 12 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 3 | 9 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 8 | 1 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 5 | 26 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | Missing | 0 Participants |
| Spiolto® Respimat®, Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 1 | 0 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | Missing | 2 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 1 | 1 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 2 | 3 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 3 | 18 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 4 | 31 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 5 | 25 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 6 | 28 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 7 | 9 Participants |
| Triple-Therapy (LAMA/LABA/ICS), Propensity Score Matched 1(Triple-Therapy) to 1(Spiolto) | Patients' General Condition According to the Physician's Global Evaluation (PGE) Score at the End of the Observation Period | PGE score 8 | 2 Participants |