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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00624377
First received: February 19, 2008
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.


Enrollment: 2031
Study Start Date: December 2007
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
COPD patients Drug: Tiotropium
Tiotropium 18 mcg HandiHaler once daily

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

COPD

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®.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 3
Kaohsiung, Taiwan
Boehringer Ingelheim Investigational Site 2
Kaohsiung, Taiwan
Boehringer Ingelheim Investigational Site 1
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 6
Taipiei, Taiwan
Boehringer Ingelheim Investigational Site 5
Taipiei, Taiwan
Boehringer Ingelheim Investigational Site 4
Taipiei, Taiwan
Boehringer Ingelheim Investigational Site 3
Taipiei, Taiwan
Boehringer Ingelheim Investigational Site 2
Taipiei, Taiwan
Boehringer Ingelheim Investigational Site 1
Taipiei, Taiwan
Boehringer Ingelheim Investigational Site
Taoyuan, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00624377     History of Changes
Other Study ID Numbers: 205.399
Study First Received: February 19, 2008
Results First Received: February 23, 2012
Last Updated: February 27, 2014
Health Authority: Taiwan: DOH(Department of Health)

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014