Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The decrease in physical activity due to increasing dyspnoea that over time leads to a steadily worsening condition and increasing restriction of physical functioning is a key problem for COPD patients and affects even the early stages. Clinical studies to investigate both Spiriva® and Striverdi® Respimat® have demonstrated a marked improvement in physical exercise capacity. However, there have so far been no data from the daily practice setting about everyday functioning on combination treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in patients requiring treatment with 2 long-acting bronchodilators. The objective of this NIS is to measure changes in physical functioning as a surrogate for physical activity and exercise capacity in COPD patients on treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in routine daily treatment (so-called real life setting).
Interventions
Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®
DRUGStriverdi® Respimat®
Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®
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
* Female and male patients \>= 40 years * COPD GOLD 2014 B - D * Treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat® acc. to the Summary of Product Characteristics (SmPC), no change of routine diagnostics and treatment * Signed informed consent form before inclusion into the non-interventional study (NIS)
Exclusion criteria
* Patients with contraindications acc. to the Summary of Product Characteristics (SmPC) * pregnant and breastfeeding women * patients who are taking part in a different non-interventional study (NIS) or an interventional clinical study at the same time are not to be enrolled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Therapeutic Success | Baseline and 4-6 weeks | Percentage of participants with therapeutic success defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks. The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| General Health of the Patient at Baseline | Baseline | General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score at the initial examination. The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent). |
| General Health of the Patient After 4-6 Weeks | 4-6 weeks | General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score after 4-6 weeks. The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent). |
| Absolute Changes in the PF-10 Score | 4-6 weeks | Absolute changes in the PF-10 score. The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning. |
| Patient Satisfaction: Satisfaction With Inhaler | 4-6 weeks | Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7). |
| Patient Satisfaction: Satisfaction With Handling of Inhaler | 4-6 weeks | Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7). |
| Patient Satisfaction: Overall Satisfaction | 4-6 weeks | Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7). |
Countries
Germany
Participant flow
Recruitment details
An open, prospective non-interventional study in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Participants by arm
| Arm | Count |
|---|---|
| All Patients Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat | 1,858 |
| Total | 1,858 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 4 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 67.41 Years STANDARD_DEVIATION 10.19 |
| Sex: Female, Male Female | 770 Participants |
| Sex: Female, Male Male | 1088 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,298 | 0 / 560 |
| serious Total, serious adverse events | 30 / 1,298 | 12 / 560 |
Outcome results
Primary
Percentage of Participants With Therapeutic Success
Percentage of participants with therapeutic success defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks. The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.
Time frame: Baseline and 4-6 weeks
Population: Full analysis (FAS) which includes all patients enrolled in the study who did not violated any inclusion or exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Percentage of Participants With Therapeutic Success | Therapy successful | 48.90 Percentage of participants |
| All Patients | Percentage of Participants With Therapeutic Success | Therapy not successful | 51.10 Percentage of participants |
Secondary
Absolute Changes in the PF-10 Score
Absolute changes in the PF-10 score. The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning.
Time frame: 4-6 weeks
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Patients | Absolute Changes in the PF-10 Score | 10.15 Units on a scale | Standard Deviation 19.22 |
Secondary
General Health of the Patient After 4-6 Weeks
General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score after 4-6 weeks. The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent).
Time frame: 4-6 weeks
Population: FAS including patients with available PGE score at end of study visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | General Health of the Patient After 4-6 Weeks | 1 (poor) | 0.96 Percentage of participants |
| All Patients | General Health of the Patient After 4-6 Weeks | 2 | 5.48 Percentage of participants |
| All Patients | General Health of the Patient After 4-6 Weeks | 3 | 13.67 Percentage of participants |
| All Patients | General Health of the Patient After 4-6 Weeks | 4 | 22.60 Percentage of participants |
| All Patients | General Health of the Patient After 4-6 Weeks | 5 | 25.08 Percentage of participants |
| All Patients | General Health of the Patient After 4-6 Weeks | 6 | 22.09 Percentage of participants |
| All Patients | General Health of the Patient After 4-6 Weeks | 7 | 8.25 Percentage of participants |
| All Patients | General Health of the Patient After 4-6 Weeks | 8 (excellent) | 1.86 Percentage of participants |
Secondary
General Health of the Patient at Baseline
General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score at the initial examination. The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent).
Time frame: Baseline
Population: FAS including patients with available PGE score at baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | General Health of the Patient at Baseline | 1 (poor) | 2.10 Percentage of participants |
| All Patients | General Health of the Patient at Baseline | 2 | 14.72 Percentage of participants |
| All Patients | General Health of the Patient at Baseline | 3 | 25.73 Percentage of participants |
| All Patients | General Health of the Patient at Baseline | 4 | 29.13 Percentage of participants |
| All Patients | General Health of the Patient at Baseline | 5 | 16.57 Percentage of participants |
| All Patients | General Health of the Patient at Baseline | 6 | 9.44 Percentage of participants |
| All Patients | General Health of the Patient at Baseline | 7 | 2.16 Percentage of participants |
| All Patients | General Health of the Patient at Baseline | 8 (excellent) | 0.11 Percentage of participants |
Secondary
Patient Satisfaction: Overall Satisfaction
Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).
Time frame: 4-6 weeks
Population: FAS including patients with available satisfaction data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Patient Satisfaction: Overall Satisfaction | Very satisifed | 25.21 Percentage of participants |
| All Patients | Patient Satisfaction: Overall Satisfaction | Satisfied | 42.13 Percentage of participants |
| All Patients | Patient Satisfaction: Overall Satisfaction | Rather satisfied | 13.53 Percentage of participants |
| All Patients | Patient Satisfaction: Overall Satisfaction | Neither satisfied or dissatisfied | 9.70 Percentage of participants |
| All Patients | Patient Satisfaction: Overall Satisfaction | Rather dissatisfied | 4.29 Percentage of participants |
| All Patients | Patient Satisfaction: Overall Satisfaction | Dissatisfied | 4.06 Percentage of participants |
| All Patients | Patient Satisfaction: Overall Satisfaction | Very dissatisfied | 1.07 Percentage of participants |
Secondary
Patient Satisfaction: Satisfaction With Handling of Inhaler
Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).
Time frame: 4-6 weeks
Population: FAS including patients with available handling of inhaler satisfaction data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Patient Satisfaction: Satisfaction With Handling of Inhaler | Rather satisfied | 11.25 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Handling of Inhaler | Neither satisfied or dissatisfied | 5.06 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Handling of Inhaler | Very satisifed | 31.44 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Handling of Inhaler | Satisfied | 49.32 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Handling of Inhaler | Rather dissatisfied | 1.57 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Handling of Inhaler | Dissatisfied | 0.96 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Handling of Inhaler | Very dissatisfied | 0.39 Percentage of participants |
Secondary
Patient Satisfaction: Satisfaction With Inhaler
Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat. Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7).
Time frame: 4-6 weeks
Population: FAS including patients with available inhaler satisfaction data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients | Patient Satisfaction: Satisfaction With Inhaler | Very satisifed | 31.53 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Inhaler | Satisfied | 49.86 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Inhaler | Rather satisfied | 10.06 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Inhaler | Neither satisfied or dissatisfied | 5.12 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Inhaler | Rather dissatisfied | 1.52 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Inhaler | Dissatisfied | 1.46 Percentage of participants |
| All Patients | Patient Satisfaction: Satisfaction With Inhaler | Very dissatisfied | 0.45 Percentage of participants |