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OpenTrials
Completed

NCT Number: NCT00624377

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

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.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site, Chan Wha, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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®.

Treatment and study plan

Tiotropium

Drug

Tiotropium 18 mcg HandiHaler once daily

Primary outcomes

  1. 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

    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?"

  2. Changes of FEV1 (Forced Expiratory Volume In 1 Second) After 8 Weeks of Treatment

    Time frame: 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

  3. Changes of FEV1/FVC (Forced Vital Capacity) After 8 Weeks of Treatment

    Time frame: 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 outcomes

  1. 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

    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?"

  2. 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

    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?"

  3. 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

    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?"

  4. 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

    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?"

  5. Percentage of Participants Which Had a Reduction of Concomitant Drug Use

    Time frame: 8 weeks

    The Physician has been asked to record any prescribed and other medication used for COPD (at the physician discretion) at every visit.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
First posted
Feb 27, 2008
Registry last updated
Mar 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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