An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 188 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-10.
Sponsored by Boehringer Ingelheim · Observational
This observational non-interventional study is designed to demonstrate the improvement of physical function in COPD patients on treatment with Spiriva Respimat and allows adverse events to be recorded and evaluated.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 1,280 is above the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases 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
COPD patients who require treatment with longacting anticholinergic
Exclusion Criteria:
Patients cannot be recruited if any of the general or specific contraindications listed in the Patient information leaflet or the Summary of Product Characteristics applies. Spiriva® Respimat® is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients.
Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks
Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)
Time frame: Baseline and after 6 weeks of treatment
Change From Baseline in the PF-10 Score After 6 Weeks
Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)
Time frame: Baseline and after 6 weeks of treatment
Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety
Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications "poor" (1, 2), "satisfactory" (3, 4), "good" (5, 6), and "excellent" (7, 8))
Time frame: Baseline and after 6 weeks of treatment
Patients' Satisfaction After 6 Weeks of Treatment
Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment ("very satisfied", "satisfied", "rather satisfied", "neither satisfied nor "unsatisfied", "rather unsatisfied", "unsatisfied", and "very unsatisfied")
Time frame: 6 weeks
| Milestone | Spiriva® Respimat® 2 Puffs Once Daily at the Same Time |
|---|---|
| Started | 1280 |
| Completed | 1223 |
| Not completed | 57 |
| Withdrew: Adverse event | 36 |
| Withdrew: Individual different reasons | 21 |
Main efficacy measure was therapeutic success rate defined as an improvement from baseline after 6 weeks by at least 10 score points in the PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)
| Percentage of participants | Spiriva® Respimat® 2 Puffs Once Daily at the Same Time |
|---|---|
| Therapeutic Success as Change From Baseline in Physical Functioning After 6 Weeks | 61.5 |
Numerical changes in physical functioning (PF-10) after 6 weeks of treatment. PF-10 (subdomain of SF-36) score (range from 0 to 100, 0 reflects worst and 100 best condition)
| PF-10 score points | Spiriva® Respimat® 2 Puffs Once Daily at the Same Time |
|---|---|
| Change From Baseline in the PF-10 Score After 6 Weeks | 13.4 ± 15.9 |
Changes in Physician's Global Evaluation in physical functioning from baseline after 6 weeks of treatment (measured as 8 point scale with classifications "poor" (1, 2), "satisfactory" (3, 4), "good" (5, 6), and "excellent" (7, 8))
| PGE scale points | Spiriva® Respimat® 2 Puffs Once Daily at the Same Time |
|---|---|
| Change From Baseline After 6 Weeks in Physician's Global Evaluation (PGE) Form Safety | 1.1 ± 1.2 |
Patients' satisfaction with the Spiriva® Respimat® device after 6 weeks of treatment ("very satisfied", "satisfied", "rather satisfied", "neither satisfied nor "unsatisfied", "rather unsatisfied", "unsatisfied", and "very unsatisfied")
| Participants | Spiriva® Respimat® 2 Puffs Once Daily at the Same Time |
|---|---|
| Very satisfied | 433 |
| Satisfied | 551 |
| Rather satisfied | 145 |
| Neither / nor | 77 |
| Rather dissatisfied | 24 |
| Dissatisfied | 21 |
| Very dissatisfied | 9 |
Collected over 6 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spiriva® Respimat® 2 Puffs Once Daily at the Same Time | — | 6/1,280 (0.5%) | 0/1,280 (0%) |
| Event | Spiriva® Respimat® 2 Puffs Once Daily at the Same Time |
|---|---|
| Bronchitis, Infective exacerbation of chronic obstructive airways disease, Urinary tract infectionInfections and infestations | 3/1280 |
| Bronchial carcinoma, Laryngeal cancer, Metastatic renal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/1280 |
| Dyspnoea, Pleural effusion, Sputum discolouredRespiratory, thoracic and mediastinal disorders | 2/1280 |
| TachycardiaCardiac disorders | 1/1280 |
| ConstipationGastrointestinal disorders | 1/1280 |
| ConvulsionNervous system disorders | 1/1280 |
| Azotaemia, Urinary retentionRenal and urinary disorders | 1/1280 |
| BPHReproductive system and breast disorders | 1/1280 |
| Circulatory collapseVascular disorders | 1/1280 |
| Age, Continuous(Years) | Spiriva® Respimat® 2 Puffs Once Daily at the Same Time |
|---|---|
| Mean | 65.5 ± 10.6 |
| Sex: Female, Male(Participants) | Spiriva® Respimat® 2 Puffs Once Daily at the Same Time |
|---|---|
| Female | 500 |
| Male | 780 |
Showing the first 100 of 188 sites.
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim