Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium

• Registration Number: NCT00624377
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-02-27
• Primary Completion: 2010-03
• Results First Submitted: 2012-02-23
• Results First Submitted QC: 2012-04-16
• Results First Posted: 2012-05-15
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2031

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD patients	Tiotropium	-

Primary Outcome Measures

Name	Time	Method
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	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	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	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

Name	Time	Method
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment	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	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	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	8 weeks	The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.
Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment	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?"

Trial Locations

Locations (7)

Boehringer Ingelheim Investigational Site 1; 🇨🇳 Taipiei, Taiwan

Boehringer Ingelheim Investigational Site 5; 🇨🇳 Taipiei, Taiwan

Boehringer Ingelheim Investigational Site; 🇨🇳 Taoyuan, Taiwan

Boehringer Ingelheim Investigational Site 6; 🇨🇳 Taipiei, Taiwan

Boehringer Ingelheim Investigational Site 2; 🇨🇳 Taipiei, Taiwan

Boehringer Ingelheim Investigational Site 4; 🇨🇳 Taipiei, Taiwan

Boehringer Ingelheim Investigational Site 3; 🇨🇳 Taipiei, Taiwan