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

NCT00624377 | Completed Results

• 1 other identifier: 205.399
• Study Type: observational
• Target: 2,031
• Locations: 1 country
• Sites: 16

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

• Percentage of Participants Which Had a Reduction of Concomitant Drug Use

  8 weeks

Study Arms (1)

COPD patients

Drug: Tiotropium

Interventions

Tiotropium DRUG

Tiotropium 18 mcg HandiHaler once daily

COPD patients

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COPD

You may qualify if:

• 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.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (16)

Boehringer Ingelheim Investigational Site

Chan Wha, Taiwan

Location

Boehringer Ingelheim Investigational Site

Chiayi City, Taiwan

Location

Boehringer Ingelheim Investigational Site

Hwa Lian, Taiwan

Location

Boehringer Ingelheim Investigational Site 1

Kaohsiung City, Taiwan

Location

Boehringer Ingelheim Investigational Site 2

Kaohsiung City, Taiwan

Location

Boehringer Ingelheim Investigational Site 3

Kaohsiung City, Taiwan

Location

Boehringer Ingelheim Investigational Site 1

Taichung, Taiwan

Location

Boehringer Ingelheim Investigational Site 2

Taichung, Taiwan

Location

Boehringer Ingelheim Investigational Site

Tainan, Taiwan

Location

Boehringer Ingelheim Investigational Site 1

Taipiei, Taiwan

Location

Boehringer Ingelheim Investigational Site 2

Taipiei, Taiwan

Location

Boehringer Ingelheim Investigational Site 3

Taipiei, Taiwan

Location

Boehringer Ingelheim Investigational Site 4

Taipiei, Taiwan

Location

Boehringer Ingelheim Investigational Site 5

Taipiei, Taiwan

Location

Boehringer Ingelheim Investigational Site 6

Taipiei, Taiwan

Location

Boehringer Ingelheim Investigational Site

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 27, 2008
• Study Start: December 1, 2007
• Primary Completion: March 1, 2010
• Last Updated: March 28, 2014
• Results First Posted: May 15, 2012

Record last verified: 2014-02

Locations

TW (16)