Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.
Detailed description
The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice. In visit 1, patient data on demographics, smoking status, medical history, breathlessness, general condition, health and functional status and adverse drug reactions will be collected. In visit 2, after approximately 6 weeks, data on smoking status, concomitant diseases and medication, general condition, health and functional status and adverse drug reactions will be collected; additionally data on patient satisfaction, continuation or discontinuation of treatment and the reason in case of discontinuation.
Interventions
6 weeks
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: * Written informed consent prior to participation * Female and male patients ≥40 years of age * Patients diagnosed with COPD and requiring a combination of two long-acting bronchodilators (LAMA + LABA) according to approved SmPC and GOLD COPD guideline recommendation 2017 (GOLD COPD groups B to D) * Treatment with Spiolto® Respimat® acc. to SmPC at the discretion of the physician.
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 |
|---|---|---|
| Therapeutic Success | Final visit at the end of the study, approximately 6 weeks after start of study | The primary endpoint of the study was therapeutic success 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. 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. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2 | Final visit at the end of the study, approximately 6 weeks after start of study | Absolute changes in total CCQ score and CCQ-4 score from baseline visit at the start of the study to final visit at the end of study. The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. 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. A change of 0.4 points is was considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4. |
| General Condition of the Patient | Baseline visit (Visit 1) at the start of the study and final visit at the end of the study (visit 2), approximately 6 weeks after visit 1 | General condition of the patient, evaluated by the physician (Physician's global Evaluation score) at visit 1 and visit 2. 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 (very poor) to 8 (excellent). The modified Medical Research Council (mMRC) scale was used to assess the breathlessness state of the patient before the treatment. |
| Patient Satisfaction With Spiolto® Respimat® at Visit 2 | 6 weeks | A patient satisfaction survey was performed at visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. The 7-item satisfaction scale is a self-designed Boehringer-Ingelheim scale, without a public source or validation status. |
| Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 | 6 weeks | To assess the willingness to continue treatment with Spiolto® Respimat® at visit 2 patients were asked a yes/no question if they would continue the treatment. |
Countries
Germany
Participant flow
Recruitment details
Chronic obstructive pulmonary disease patients receiving treatment with Spiolto® Respimat® for approximately 6 weeks in routine clinical practice
Pre-assignment details
All subjects were screened for eligibility to participate in trial. Subjects attended specialist site to ensure that they (the subjects) met all implemented inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Spiolto® Respimat® at Study Start Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution Baseline visit at the start of the study | 1,322 |
| Total | 1,322 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Visit 1 | No registration after visit 1 | 9 |
| Visit 1 | No treatment documented | 10 |
| Visit 1 | No visit 1 | 10 |
| Visit 2 | Available CCQ score at visit 1 only | 109 |
| Visit 2 | Available total CCQ score at vist 2 only | 44 |
| Visit 2 | No available total CCQ score at all | 29 |
Baseline characteristics
| Characteristic | Spiolto® Respimat® at Study Start | — |
|---|---|---|
| Age, Continuous | 65.63 Years STANDARD_DEVIATION 10.09 | — |
| CCQ Score Functional state (CCQ-4) (Items: 7-10) | 3.05 Score STANDARD_DEVIATION 1.24 | — |
| CCQ Score Mental state (Items: 3; 4) | 2.69 Score STANDARD_DEVIATION 1.58 | — |
| CCQ Score Symptom (Items: 1; 2; 5; 6) | 3.42 Score STANDARD_DEVIATION 1.13 | — |
| CCQ Score Total CCQ score (All subscales) | 3.12 Score STANDARD_DEVIATION 1.09 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 562 Participants | — |
| Sex: Female, Male Male | 760 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 1,322 |
| other Total, other adverse events | 0 / 1,322 |
| serious Total, serious adverse events | 1 / 1,322 |
Outcome results
Primary
Therapeutic Success
The primary endpoint of the study was therapeutic success 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. 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. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4.
Time frame: Final visit at the end of the study, approximately 6 weeks after start of study
Population: All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat | Therapeutic Success | Therapy successfull | 756 Participants |
Secondary
Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2
Absolute changes in total CCQ score and CCQ-4 score from baseline visit at the start of the study to final visit at the end of study. The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. 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. A change of 0.4 points is was considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4.
Time frame: Final visit at the end of the study, approximately 6 weeks after start of study
Population: All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spiolto® Respimat | Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2 | Symptom | 0.84 Percentage of patients (%) | Standard Deviation 1.06 |
| Spiolto® Respimat | Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2 | Functional State (CCQ-4) | 0.75 Percentage of patients (%) | Standard Deviation 1.05 |
| Spiolto® Respimat | Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2 | Mental state | 0.73 Percentage of patients (%) | Standard Deviation 1.34 |
| Spiolto® Respimat | Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2 | Total CCQ Score | 0.78 Percentage of patients (%) | Standard Deviation 0.95 |
Secondary
General Condition of the Patient
General condition of the patient, evaluated by the physician (Physician's global Evaluation score) at visit 1 and visit 2. 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 (very poor) to 8 (excellent). The modified Medical Research Council (mMRC) scale was used to assess the breathlessness state of the patient before the treatment.
Time frame: Baseline visit (Visit 1) at the start of the study and final visit at the end of the study (visit 2), approximately 6 weeks after visit 1
Population: All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spiolto® Respimat | General Condition of the Patient | Score 2 | 93 Participants |
| Spiolto® Respimat | General Condition of the Patient | Score 6 | 138 Participants |
| Spiolto® Respimat | General Condition of the Patient | Score 4 | 378 Participants |
| Spiolto® Respimat | General Condition of the Patient | Score 7 | 43 Participants |
| Spiolto® Respimat | General Condition of the Patient | Score 3 | 281 Participants |
| Spiolto® Respimat | General Condition of the Patient | Score 8 | 1 Participants |
| Spiolto® Respimat | General Condition of the Patient | Score 5 | 195 Participants |
| Spiolto® Respimat | General Condition of the Patient | Missing | 0 Participants |
| Spiolto® Respimat | General Condition of the Patient | Score 1 | 11 Participants |
| Spiolto® Respimat® Final Vist | General Condition of the Patient | Missing | 1 Participants |
| Spiolto® Respimat® Final Vist | General Condition of the Patient | Score 1 | 1 Participants |
| Spiolto® Respimat® Final Vist | General Condition of the Patient | Score 2 | 23 Participants |
| Spiolto® Respimat® Final Vist | General Condition of the Patient | Score 3 | 95 Participants |
| Spiolto® Respimat® Final Vist | General Condition of the Patient | Score 4 | 223 Participants |
| Spiolto® Respimat® Final Vist | General Condition of the Patient | Score 5 | 350 Participants |
| Spiolto® Respimat® Final Vist | General Condition of the Patient | Score 6 | 325 Participants |
| Spiolto® Respimat® Final Vist | General Condition of the Patient | Score 7 | 102 Participants |
| Spiolto® Respimat® Final Vist | General Condition of the Patient | Score 8 | 20 Participants |
Secondary
Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2
To assess the willingness to continue treatment with Spiolto® Respimat® at visit 2 patients were asked a yes/no question if they would continue the treatment.
Time frame: 6 weeks
Population: Patients with a performed visit 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spiolto® Respimat | Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 | 1194 Participants |
Secondary
Patient Satisfaction With Spiolto® Respimat® at Visit 2
A patient satisfaction survey was performed at visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. The 7-item satisfaction scale is a self-designed Boehringer-Ingelheim scale, without a public source or validation status.
Time frame: 6 weeks
Population: All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient overall satisfaction | Very satisfied | 427 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient overall satisfaction | Satisfied | 544 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient overall satisfaction | Rather satisfied | 95 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient overall satisfaction | Neither satisfied nor dissatisfied | 46 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient overall satisfaction | Rather dissatisfied | 13 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient overall satisfaction | Dissatisfied | 12 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient overall satisfaction | Very dissatisfied | 3 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with inhaling | Very satisfied | 429 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with inhaling | Satisfied | 579 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with inhaling | Rather satisfied | 85 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with inhaling | Neither satisfied nor dissatisfied | 33 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with inhaling | Rather dissatisfied | 8 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with inhaling | Dissatisfied | 4 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with inhaling | Very dissatisfied | 2 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with handling | Very satisfied | 389 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with handling | Satisfied | 590 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with handling | Rather satisfied | 116 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with handling | Neither satisfied nor dissatisfied | 24 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with handling | Rather dissatisfied | 16 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with handling | Dissatisfied | 4 Participants |
| Spiolto® Respimat | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | Patient satisfaction with handling | Very dissatisfied | 1 Participants |