Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
Open-label observational study which includes COPD patients that are receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations.
Interventions
Drug
Sponsors
Boehringer Ingelheim
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent prior to participation * Female and male patients ≥40 years of age * Patients diagnosed with COPD and based upon the investigator's decision requiring a new prescription of Spiolto Respimat® (combination of two long-acting bronchodilators) according to Spiolto® Respimat® SmPC, GOLD COPD Strategy Document 2018 (GOLD COPD groups B to D) and local COPD guidelines
Exclusion criteria
* Patients with contraindications according to Spiolto® Respimat® SmPC * Patients already on a LABA/LAMA combination (free and fixed dose) in the last 6 weeks before study entry * Patients continuing LABA/ICS treatment should not be additionally treated with Spiolto® Respimat® in order to avoid a double dosing of long-acting beta-agonists * Pregnancy and lactation * Current participation in any clinical trial or any other non-interventional study of a drug or device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2 | At Visit 2 (6 weeks after baseline visit 1) | Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) | At visit 1 | PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent). |
| Physician's Global Evaluation (PGE) Score at Visit 2 | At visit 2 (6 weeks after baseline visit 1) | PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent). |
| Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 | At visit 2 (6 weeks after baseline visit 1) | Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported. |
| Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2 | At baseline visit 1 and 6 weeks thereafter at visit 2 | The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. Symptom domain covered 4 questions (number 1, 2, 5, 6), Functional state domain covered 4 questions (number 7, 8, 9, 10), and Mental state domain covered 2 questions (number 3, 4). Scores for the questions in each domain were summed up and divided by the number of questions in each domain giving the resulting score for respective domain. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. Change of the score was calculated as visit 2 minus visit 1. |
| Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 | At visit 2 (6 weeks after baseline visit 1) | Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported. |
| Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 | At visit 2 (6 weeks after baseline visit 1) | Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported. |
| Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 | At visit 2 (6 weeks after baseline visit 1) | Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported |
Countries
Bulgaria, Czechia, Hungary, Israel, Lithuania, Poland, Romania, Russia, Slovenia, Switzerland, Ukraine
Participant flow
Recruitment details
This open-label self-controlled observational study over an observational period of 6 weeks (2 visits) was to investigate the potential changes in clinical control of Chronic Obstructive Pulmonary Disease (COPD) patients measured by the Clinical COPD Questionnaire (CCQ) during treatment with Spiolto® Respimat® in routine practice.
Pre-assignment details
All patients were screened for eligibility prior to participation in the trial. Patients attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Spiolto® Respimat® Chronic Obstructive Pulmonary Disease (COPD) patients administered a fixed dose combination of tiotropium and olodaterol (2.5 micrograms and 2.5 micrograms per puff) through Spiolto® Respimat® according to Spiolto® Respimat® Summary of Product Characteristics (SmPC) and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for 6 weeks. | 4,819 |
| Total | 4,819 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Deceased patient | 6 |
| Overall Study | Discontinuation of study | 11 |
| Overall Study | Lost to Follow-up | 18 |
| Overall Study | Never taken Spiolto® Respimat® | 1 |
| Overall Study | Not come to second visit | 3 |
| Overall Study | Not meet inclusion / exclusion criterion | 3 |
| Overall Study | Patient's request | 11 |
| Overall Study | Serious adverse event | 1 |
| Overall Study | Withdrawal of consent | 5 |
Baseline characteristics
| Characteristic | Spiolto® Respimat® | — |
|---|---|---|
| Age, Continuous | 65.38 Years STANDARD_DEVIATION 9.34 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1459 Participants | — |
| Sex: Female, Male Male | 3360 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 4,819 |
| other Total, other adverse events | 0 / 4,819 |
| serious Total, serious adverse events | 8 / 4,819 |
Outcome results
Primary
Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2
Therapeutic success of Spiolto® Respimat® treatment was defined as 0.4 point decrease in the Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire - Clinical COPD Questionnaire (CCQ) score from visit 1 to visit 2. Each of the 10 CCQ questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do) at baseline (Visit 1) and at the end of the observation after approximately 6 weeks (Visit 2). The sum of the scores divided by 10 gives the CCQ score, which measures the health and functional status. A higher CCQ score is indicative of worse status.
Time frame: At Visit 2 (6 weeks after baseline visit 1)
Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiolto® Respimat® | Percentage of Patients With Therapeutic Success of Spiolto® Respimat® Treatment at Visit 2 | 81.38 Percentage of participants |
Secondary
Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2
The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. Symptom domain covered 4 questions (number 1, 2, 5, 6), Functional state domain covered 4 questions (number 7, 8, 9, 10), and Mental state domain covered 2 questions (number 3, 4). Scores for the questions in each domain were summed up and divided by the number of questions in each domain giving the resulting score for respective domain. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. Change of the score was calculated as visit 2 minus visit 1.
Time frame: At baseline visit 1 and 6 weeks thereafter at visit 2
Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spiolto® Respimat® | Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2 | Symptom | 1.09 Score on a scale | Standard Deviation 0.97 |
| Spiolto® Respimat® | Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2 | Functional state | 0.94 Score on a scale | Standard Deviation 0.96 |
| Spiolto® Respimat® | Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2 | Mental state | 1.04 Score on a scale | Standard Deviation 1.21 |
| Spiolto® Respimat® | Changes in the Clinical COPD Questionnaire (CCQ) and the CCQ Symptom, Mental State and Functional State Domain Scores From Visit 1 (Baseline) to Visit 2 | Total CCQ score | 1.02 Score on a scale | Standard Deviation 0.87 |
Secondary
Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2
Number of participants willing to continue treatment with Spiolto® Respimat® at visit 2 was reported.
Time frame: At visit 2 (6 weeks after baseline visit 1)
Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat® | Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 | Yes | 4539 Participants |
| Spiolto® Respimat® | Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 | No | 161 Participants |
Secondary
Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2
Patient overall satisfaction with Spiolto® Respimat® treatment at visit 2 was reported.
Time frame: At visit 2 (6 weeks after baseline visit 1)
Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 | Very satisfied | 1474 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 | Satisfied | 2055 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 | Rather satisfied | 803 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 | Neither satisfied nor dissatisfied | 236 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 | Rather dissatisfied | 64 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 | Dissatisfied | 44 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 | Very dissatisfied | 20 Participants |
| Spiolto® Respimat® | Patient Overall Satisfaction With Spiolto® Respimat® Treatment at Visit 2 | Not answered | 4 Participants |
Secondary
Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2
Patient satisfaction with handling of the Respimat® inhalation device at visit 2 was reported.
Time frame: At visit 2 (6 weeks after baseline visit 1)
Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 | Very satisfied | 1554 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 | Satisfied | 2083 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 | Not answered | 6 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 | Rather satisfied | 711 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 | Neither satisfied nor dissatisfied | 244 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 | Rather dissatisfied | 60 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 | Dissatisfied | 31 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Handling of the Respimat® Inhalation Device at Visit 2 | Very dissatisfied | 11 Participants |
Secondary
Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2
Patient satisfaction with inhaling from the Respimat® device at visit 2 was reported
Time frame: At visit 2 (6 weeks after baseline visit 1)
Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 | Not answered | 8 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 | Very satisfied | 1579 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 | Satisfied | 2119 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 | Rather satisfied | 694 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 | Neither satisfied nor dissatisfied | 211 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 | Rather dissatisfied | 49 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 | Dissatisfied | 30 Participants |
| Spiolto® Respimat® | Patient Satisfaction With Inhaling From the Respimat® Device at Visit 2 | Very dissatisfied | 10 Participants |
Secondary
Physician's Global Evaluation (PGE) Score at Visit 1(Baseline)
PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).
Time frame: At visit 1
Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) | PGE score = 8 | 14 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) | PGE score = 1 | 44 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) | PGE score = 2 | 471 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) | PGE score = 3 | 1176 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) | PGE score = 4 | 1428 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) | PGE score = 5 | 888 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) | PGE score = 6 | 539 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 1(Baseline) | PGE score = 7 | 140 Participants |
Secondary
Physician's Global Evaluation (PGE) Score at Visit 2
PGE score assessed the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent).
Time frame: At visit 2 (6 weeks after baseline visit 1)
Population: Full analysis set (FAS): All screened patients with informed consent, date of registration (date of creation of screening form in the Electronic Case Report Form (eCRF)), at least one documented administration of Spiolto® Respimat®, and available total CCQ score at visit 1 and visit 2.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 2 | PGE score = 1 | 3 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 2 | PGE score = 2 | 45 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 2 | PGE score = 3 | 212 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 2 | PGE score = 4 | 661 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 2 | PGE score = 5 | 1227 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 2 | PGE score = 6 | 1468 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 2 | PGE score = 7 | 891 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 2 | PGE score = 8 | 192 Participants |
| Spiolto® Respimat® | Physician's Global Evaluation (PGE) Score at Visit 2 | Missing | 1 Participants |