Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice
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| ClinicalTrials.gov Identifier: NCT00624377 |
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Recruitment Status :
Completed
First Posted : February 27, 2008
Results First Posted : May 15, 2012
Last Update Posted : March 28, 2014
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Brief Summary:
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Pulmonary Disease, Chronic Obstructive | Drug: Tiotropium |
| Study Type : | Observational |
| Actual Enrollment : | 2031 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Safety and Effectiveness of Spiriva® in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice |
| Study Start Date : | December 2007 |
| Actual Primary Completion Date : | March 2010 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Tiotropium bromide
| Group/Cohort | Intervention/treatment |
|---|---|
| COPD patients |
Drug: Tiotropium
Tiotropium 18 mcg HandiHaler once daily |
Primary Outcome Measures :
- 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 [ Time Frame: Baseline and 8 weeks ]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?"
- Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment [ Time Frame: Baseline and 8 weeks ]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
- Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment [ Time Frame: Baseline and 8 weeks ]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%).
Secondary Outcome Measures :
- Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment [ Time Frame: Baseline and 8 weeks ]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?"
- Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment [ Time Frame: Baseline and 8 weeks ]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?"
- Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment [ Time Frame: Baseline and 8 weeks ]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?"
- 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 [ Time Frame: Baseline and 8 weeks ]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?"
- Percentage of Participants Which Had a Reduction of Concomitant Drug Use [ Time Frame: 8 weeks ]The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.
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| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
COPD
Criteria
Inclusion criteria:
- Patients with confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD; updated 2005).
- Patients who are assessed to benefit from the intake of long-acting anticholinergics as a monotherapy or as add-on medication.
- Tiotropium bromide naïve patients.
- Patients with indication for tiotropium bromide according to Taiwanese Spiriva® label.
Exclusion criteria:
- Patients with contraindications to tiotropium bromide use (as per the Spiriva® package insert).
- Known hypersensitivity to the active ingredient or to any of the excipients of Spiriva®.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624377
Locations
| Taiwan | |
| Boehringer Ingelheim Investigational Site | |
| Chan Wha, Taiwan | |
| Boehringer Ingelheim Investigational Site | |
| Chia Yi, Taiwan | |
| Boehringer Ingelheim Investigational Site | |
| Hsin Chu, Taiwan | |
| Boehringer Ingelheim Investigational Site | |
| Hwa Lian, Taiwan | |
| Boehringer Ingelheim Investigational Site 1 | |
| Kaohsiung, Taiwan | |
| Boehringer Ingelheim Investigational Site 2 | |
| Kaohsiung, Taiwan | |
| Boehringer Ingelheim Investigational Site 3 | |
| Kaohsiung, Taiwan | |
| Boehringer Ingelheim Investigational Site 1 | |
| Taichung, Taiwan | |
| Boehringer Ingelheim Investigational Site 2 | |
| Taichung, Taiwan | |
| Boehringer Ingelheim Investigational Site | |
| Tainan, Taiwan | |
| Boehringer Ingelheim Investigational Site 1 | |
| Taipiei, Taiwan | |
| Boehringer Ingelheim Investigational Site 2 | |
| Taipiei, Taiwan | |
| Boehringer Ingelheim Investigational Site 3 | |
| Taipiei, Taiwan | |
| Boehringer Ingelheim Investigational Site 4 | |
| Taipiei, Taiwan | |
| Boehringer Ingelheim Investigational Site 5 | |
| Taipiei, Taiwan | |
| Boehringer Ingelheim Investigational Site 6 | |
| Taipiei, Taiwan | |
| Boehringer Ingelheim Investigational Site | |
| Taoyuan, Taiwan | |
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00624377 |
| Other Study ID Numbers: |
205.399 |
| First Posted: | February 27, 2008 Key Record Dates |
| Results First Posted: | May 15, 2012 |
| Last Update Posted: | March 28, 2014 |
| Last Verified: | February 2014 |
Additional relevant MeSH terms:
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Tiotropium Bromide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Parasympatholytics Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |