Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region

Study Overview
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Brief Summary
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The objective of this observational study is to collect and evaluate data on Health Related Quality of Life (HRQoL) of Spiriva delivered by HandiHaler, using disease specific SGRQ in the national samples of Central & Central European patients with varying severities of chronic obstructive pulmonary disease (COPD) in the real life setting over the 6 months.

Detailed Description
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Study Design: an open-label, uncontrolled and single arm post-marketing surveillance study

Official Title
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Spiriva Observational Study Measuring Saint George's Respiratory Questionnaire (SGRQ) in Routine Medical Practice in Central & Eastern European Region

Conditions
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Pulmonary Disease, Chronic Obstructive

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 40 years and older male and female ambulatory outpatients. Clinical diagnosis of Chronic Obstructive Lung Disease (COPD) (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines: Forced expiratory Volume in one second (FEV1)/ Forced Vital Capacity (FVC) < 0.7 and FEV1 < 80% predicted). Stable patient, without exacerbation for at least one month to the study. Exclusion criteria: Uncooperative patients as judged by the physician. Patients that have any condition which, according to the participating physician's opinion, might decrease the chance of obtaining satisfactory data to achieve the objectives of the observation study. Patients with any conditions excluded as per Country specific package insert. Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD patients<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change of Total Saint George Respiratory Questionnaire (SGRQ) Score at the End of the Observational Period After 6 Months From Baseline | The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life) | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Bronchodilator or Inhaled Corticosteroids (ICS) | Pulmonary medication from baseline to visit 3 (6 months) | 6 months | 
| Compliance of Patients | Patients are considered to be compliant if the difference of the number of days between visit 1 (baseline) and visit 3 (6months) and the number of actual taken capsules is less than 10. | 6 months | 
| Patients With Any Adverse Events |  | 6 months |