An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2014-03-27.
Sponsored by Boehringer Ingelheim · Observational
To investigate safety and effectiveness information on the use of Tiotropium Respimat for long time of period in daily practical clinical circumstances, and to obtain proper drug use information.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 361 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.
300
Patients with COPD who is expected to be treatable with long term. All patients must have a diagnosis of COPD and register after the start of treatment of Tiotropium Respimat.
Exclusion criteria:
There is no special restriction, because this PMS is an observational investigation under conditions of normal clinical practice. 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 in Package labelling.
Incidence of Adverse Events (AEs)
The number of patient with any AEs, patients with drug-related AEs
Time frame: Week 52
Effectiveness
Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician.
Time frame: Week 52
Forced Expiratory Volume in One Second (FEV1)
FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated.
Time frame: Week 0 and Week 52
Cough Frequency
Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently.
Time frame: Week 0 and Week 52
Amount of Sputum
Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much.
Time frame: Week 0 and Week 52
Shortness of Breath
Shortness of Breath is rating 1 to 6 score based on patient's diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day.
Time frame: Week 0 and Week 52
Nocturnal Sleep
Nocturnal Sleep is rating 1 to 5 score based on patient's diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night.
Time frame: Week 0 and Week 52
A total of 361 patients were enrolled. Of these patients, the CRF of 4 patients were uncollected by reason of institution, and the 16 patients who did not visit after enrollment. Then, total 341 patients were observed in the survey.
| Milestone | Spiriva Respimat |
|---|---|
| Started | 341 |
| Completed | 248 |
| Not completed | 93 |
| Withdrew: Adverse event | 22 |
| Withdrew: Lost to follow-up | 28 |
| Withdrew: Withdrawal by subject | 25 |
| Withdrew: Other | 18 |
The number of patient with any AEs, patients with drug-related AEs
| Patients | Spiriva Respimat |
|---|---|
| patient with any AEs | 53 |
| patients with drug-related AEs | 16 |
Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician.
| Patients | Spiriva Respimat |
|---|---|
| Improved | 191 |
| No change | 122 |
| Aggravated | 3 |
FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated.
| L | Spiriva Respimat |
|---|---|
| Week 0 | 1.39 ± 0.66 |
| Week 52 | 1.46 ± 0.66 |
| Change from Week 0 to Week 52 | 0.06 ± 0.28 |
Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently.
| Units on a scale | Spiriva Respimat |
|---|---|
| Week 0 | 2.10 ± 0.69 |
| Week 52 | 1.62 ± 0.59 |
| Change from Week 0 to Week 52 | -0.47 ± 0.63 |
Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much.
| Units on a scale | Spiriva Respimat |
|---|---|
| Week 0 | 2.05 ± 0.74 |
| Week 52 | 1.63 ± 0.61 |
| Change from Week 0 to Week 52 | -0.42 ± 0.63 |
Shortness of Breath is rating 1 to 6 score based on patient's diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day.
| Units on a scale | Spiriva Respimat |
|---|---|
| Week 0 | 3.28 ± 1.29 |
| Week 52 | 2.69 ± 1.34 |
| Change from Week 0 to Week 52 | -0.59 ± 0.82 |
Nocturnal Sleep is rating 1 to 5 score based on patient's diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night.
| Units on a scale | Spiriva Respimat |
|---|---|
| Week 0 | 1.55 ± 0.84 |
| Week 52 | 1.25 ± 0.60 |
| Change from Week 0 to Week 52 | -0.31 ± 0.58 |
Collected over 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spiriva Respimat | — | 27/341 (7.9%) | 0/341 (0%) |
| Event | Spiriva Respimat |
|---|---|
| PneumoniaInfections and infestations | 4/341 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 4/341 |
| Pneumonia bacterialInfections and infestations | 3/341 |
| Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/341 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 3/341 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 3/341 |
| Femoral neck fractureInjury, poisoning and procedural complications | 2/341 |
| Interstitial lung diseaseRespiratory, thoracic and mediastinal disorders | 2/341 |
| Cardiac failureCardiac disorders | 1/341 |
| Cor pulmonaleCardiac disorders | 1/341 |
| Age, Continuous(years) | Spiriva Respimat |
|---|---|
| Mean | 73.6 ± 9.0 |
| Sex: Female, Male(Participants) | Spiriva Respimat |
|---|---|
| Female | 47 |
| Male | 294 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Boehringer Ingelheim