An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 17 sites in Taiwan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-03-28.
Sponsored by Boehringer Ingelheim · Observational
The purpose of this study is to monitor the change in the health status of severe COPD patients after the initiation of Tiotropium therapy. This will be assessed by the physician's global evaluation of the patient's health status on a 8-point scale. This measure has been shown to correlate with a established standard measure of the patients health related quality of life. The primary analysis in this trial will only include patients not pre-treated with a long-acting beta-agonist to establish a clear efficacy signal in this patient population. As the reality of COPD treatment nowadays is poly-pharmacy, a secondary analysis will analyse patients who are pretreated with long-acting bronchodilators to put the changes in the health status in a likely real world context. In parallel to these evaluations of the health status, the lung function response of the patients will be assessed to gain an established objective measure of treatment response.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 2,031 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.
COPD
Exclusion criteria:
Drug: Tiotropium
Tiotropium 18 mcg HandiHaler once daily
Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
Time frame: Baseline and 8 weeks
Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment
FEV1: Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value is considered normal. FEV1 \< 80% of the predicted value in combination with an FEV1/FVC \< 70% confirms the presence of airflow limitation that is not fully reversible
Time frame: Baseline and 8 weeks
Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment
FEV1/FVC (FEV1%) is the ratio of FEV1 to FVC. In healthy adults this should be approximately 75-80%. In obstructive diseases, the value often decreased (\<80%, often \~45%).
Time frame: Baseline and 8 weeks
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
Time frame: Baseline and 8 weeks
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
Time frame: Baseline and 8 weeks
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
Time frame: Baseline and 8 weeks
Change of Patient's Global COPD Assessment (8-point Scale) After 8-week of Treatment Grouped According to Patients Severity and Concomitant Medication With LABAs
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
Time frame: Baseline and 8 weeks
Percentage of Participants Which Had a Reduction of Concomitant Drug Use
The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.
Time frame: 8 weeks
A total of 2,031 patients were enrolled between Jan-11-2008 to Mar-24-2010
| Milestone | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Started | 2031 |
| Completed | 1387 |
| Not completed | 644 |
| Withdrew: Lost to follow-up | 355 |
| Withdrew: Withdrawal by subject | 100 |
| Withdrew: Adverse event | 14 |
| Withdrew: Other | 91 |
| Withdrew: Non-evaluable population | 84 |
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
| Units on a Scale | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Change of Physician's Global COPD (Chronic Obstructive Pulmonary Disease) Assessment After 8-week of Treatment Severe COPD Patients Without Concomitant LABA (Long-acting Beta Agonists) Treatment | 1.16 ± 1.34 |
FEV1: Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value is considered normal. FEV1 \< 80% of the predicted value in combination with an FEV1/FVC \< 70% confirms the presence of airflow limitation that is not fully reversible
| liter per second | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment | 6.27 ± 12.99 |
FEV1/FVC (FEV1%) is the ratio of FEV1 to FVC. In healthy adults this should be approximately 75-80%. In obstructive diseases, the value often decreased (\<80%, often \~45%).
| Ratio | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment | 4.36 ± 10.72 |
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
| Units on a Scale | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment | 1.72 ± 1.77 |
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
| Units on a Scale | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment | 1.19 ± 1.31 |
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
| Units on a Scale | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment | 1.54 ± 1.67 |
The extent of satisfaction with tiotropium bromide treatment was evaluated based on the changes of the Global COPD Assessment performed by the physician. This evaluation was done with the help of an 8-point scale rated from 1 (Poor) to 8 (Excellent) following the question "Overall, how is the COPD of your patient?"
| Units on a Scale | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Change of Patient's Global COPD Assessment (8-point Scale) After 8-week of Treatment Grouped According to Patients Severity and Concomitant Medication With LABAs | 2.84 ± 2.21 |
The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.
| Percentage of Participants | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Percentage of Participants Which Had a Reduction of Concomitant Drug Use | 76 |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spiriva 18µg With HandiHaler Device on COPD Patients | — | 16/2,031 (0.8%) | 0/2,031 (0%) |
| Event | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Chronic Obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 4/2031 |
| DeathGeneral disorders | 2/2031 |
| Acute Myocardial InfarctionCardiac disorders | 2/2031 |
| Cardiac disorderCardiac disorders | 1/2031 |
| Hepatic cirrhosisHepatobiliary disorders | 1/2031 |
| PneumoniaInfections and infestations | 1/2031 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/2031 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/2031 |
| Respiratory therapySurgical and medical procedures | 1/2031 |
| InfarctionVascular disorders | 1/2031 |
| Age, Customized(Year) | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Mean | 72.87 ± 10.32 |
| Gender(Participants) | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Female | 245 |
| Male | 1781 |
| Weight(kg) | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Mean | 61.94 ± 11.60 |
| Height(cm) | Spiriva 18µg With HandiHaler Device on COPD Patients |
|---|---|
| Mean | 162.57 ± 7.38 |
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boehringer Ingelheim