An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 701 sites in Germany. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-06-05.
Sponsored by Boehringer Ingelheim · Observational
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).
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 1,845 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients
Exclusion criteria:
Drug: Spiriva® Respimat® · Drug: Striverdi® Respimat®
Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®
Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®
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
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
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
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
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
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
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
An open, prospective non-interventional study in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
| Milestone | All Patients |
|---|---|
| Started | 1858 |
| Completed | 1854 |
| Not completed | 4 |
| Withdrew: Protocol violation | 4 |
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.
| Percentage of participants | All Patients |
|---|---|
| Therapy successful | 48.90 |
| Therapy not successful | 51.10 |
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.
| Units on a scale | All Patients |
|---|---|
| Absolute Changes in the PF-10 Score | 10.15 ± 19.22 |
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).
| Percentage of participants | All Patients |
|---|---|
| 1 (poor) | 2.10 |
| 2 | 14.72 |
| 3 | 25.73 |
| 4 | 29.13 |
| 5 | 16.57 |
| 6 | 9.44 |
| 7 | 2.16 |
| 8 (excellent) | 0.11 |
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).
| Percentage of participants | All Patients |
|---|---|
| 1 (poor) | 0.96 |
| 2 | 5.48 |
| 3 | 13.67 |
| 4 | 22.60 |
| 5 | 25.08 |
| 6 | 22.09 |
| 7 | 8.25 |
| 8 (excellent) | 1.86 |
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).
| Percentage of participants | All Patients |
|---|---|
| Very satisifed | 25.21 |
| Satisfied | 42.13 |
| Rather satisfied | 13.53 |
| Neither satisfied or dissatisfied | 9.70 |
| Rather dissatisfied | 4.29 |
| Dissatisfied | 4.06 |
| Very dissatisfied | 1.07 |
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).
| Percentage of participants | All Patients |
|---|---|
| Very satisifed | 31.53 |
| Satisfied | 49.86 |
| Rather satisfied | 10.06 |
| Neither satisfied or dissatisfied | 5.12 |
| Rather dissatisfied | 1.52 |
| Dissatisfied | 1.46 |
| Very dissatisfied | 0.45 |
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).
| Percentage of participants | All Patients |
|---|---|
| Very satisifed | 31.44 |
| Satisfied | 49.32 |
| Rather satisfied | 11.25 |
| Neither satisfied or dissatisfied | 5.06 |
| Rather dissatisfied | 1.57 |
| Dissatisfied | 0.96 |
| Very dissatisfied | 0.39 |
Collected over From start of study until 21 days after permanent discontinuation of study therapy or end of study, up to 9 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spiriva Respimat + Striverdi Respimat | — | 30/1,298 (2.3%) | 0/1,298 (0%) |
| Spiriva 18 mcg + Striverdi Respimat | — | 12/560 (2.1%) | 0/560 (0%) |
| Event | Spiriva Respimat + Striverdi Respimat | Spiriva 18 mcg + Striverdi Respimat |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 8/1298 | 2/560 |
| Atrial flutterCardiac disorders | 0/1298 | 1/560 |
| Cardiac arrestCardiac disorders | 0/1298 | 1/560 |
| Cardiac failureCardiac disorders | 2/1298 | 1/560 |
| DeathGeneral disorders | 1/1298 | 1/560 |
| Sudden cardiac deathGeneral disorders | 0/1298 | 1/560 |
| Gastroenteritis clostridialInfections and infestations | 0/1298 | 1/560 |
| Spinal fractureInjury, poisoning and procedural complications | 0/1298 | 1/560 |
| Decreased appetiteMetabolism and nutrition disorders | 0/1298 | 1/560 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/1298 | 1/560 |
Treated set which includes all patients with baseline visit data.
| Age, Continuous(Years) | All Patients |
|---|---|
| Mean | 67.41 ± 10.19 |
| Sex: Female, Male(Participants) | All Patients |
|---|---|
| Female | 770 |
| Male | 1088 |
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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Boehringer Ingelheim