Clinical trial NCT00624377: Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice
Official title: Safety and Effectiveness of Spiriva® in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-27
Enrollment: 2031
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD

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.


Eligibility criteria: 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®.

Primary outcomes:
measure: 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
timeFrame: Baseline and 8 weeks
measure: Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment
timeFrame: Baseline and 8 weeks
measure: Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in Severe COPD Patients Independent of Concomitant LABA Treatment
timeFrame: Baseline and 8 weeks
measure: Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Without Concomitant LABA Treatment
timeFrame: Baseline and 8 weeks
measure: Change of Physician's Global COPD Assessment (8-point Scale) After 8-week of Treatment in All COPD Patients Independent of Concomitant LABA Treatment
timeFrame: Baseline and 8 weeks
measure: 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
timeFrame: Baseline and 8 weeks
measure: Percentage of Participants Which Had a Reduction of Concomitant Drug Use
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chan Wha
country: Taiwan
facility: Boehringer Ingelheim Investigational Site
city: Chia Yi
country: Taiwan
facility: Boehringer Ingelheim Investigational Site
city: Hsin Chu
country: Taiwan
facility: Boehringer Ingelheim Investigational Site
city: Hwa Lian
country: Taiwan
facility: Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: Boehringer Ingelheim Investigational Site 1
city: Kaohsiung
country: Taiwan
facility: Boehringer Ingelheim Investigational Site 2
city: Kaohsiung
country: Taiwan
facility: Boehringer Ingelheim Investigational Site 3
city: Taichung
country: Taiwan
facility: Boehringer Ingelheim Investigational Site 1
city: Taichung
country: Taiwan
facility: Boehringer Ingelheim Investigational Site 2
city: Tainan
country: Taiwan
facility: Boehringer Ingelheim Investigational Site
city: Taipiei
country: Taiwan
facility: Boehringer Ingelheim Investigational Site 1
city: Taipiei
country: Taiwan
facility: Boehringer Ingelheim Investigational Site 2
city: Taipiei
country: Taiwan
facility: Boehringer Ingelheim Investigational Site 3
city: Taipiei
country: Taiwan
facility: Boehringer Ingelheim Investigational Site 4
city: Taipiei
country: Taiwan
facility: Boehringer Ingelheim Investigational Site 5
city: Taipiei
country: Taiwan
facility: Boehringer Ingelheim Investigational Site 6
city: Taoyuan
country: Taiwan
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: