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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624377
• Other study ID #: 205.399
• Status: Completed
• Phase: N/A
• First received: February 19, 2008
• Last updated: February 27, 2014
• Start date: December 2007

Study information

• Verified date: February 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: DOH(Department of Health)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2031
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion criteria:

1. Patients with confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD; updated 2005).

2. Patients who are assessed to benefit from the intake of long-acting anticholinergics as a monotherapy or as add-on medication.

3. Tiotropium bromide naïve patients.

4. Patients with indication for tiotropium bromide according to Taiwanese Spiriva® label.

Exclusion criteria:

1. Patients with contraindications to tiotropium bromide use (as per the Spiriva® package insert).

2. Known hypersensitivity to the active ingredient or to any of the excipients of Spiriva®.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium
Tiotropium 18 mcg HandiHaler once daily

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?"	Baseline and 8 weeks	No
Primary	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	Baseline and 8 weeks	No
Primary	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%).	Baseline and 8 weeks	No
Secondary	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?"	Baseline and 8 weeks	No
Secondary	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?"	Baseline and 8 weeks	No
Secondary	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?"	Baseline and 8 weeks	No
Secondary	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?"	Baseline and 8 weeks	No
Secondary	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.	8 weeks	No