RUSSE / Russian Spiriva® Safety & Efficacy Study

Study Overview
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Brief Summary
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At the moment, there is hardly any structured safety and efficacy data collection on Tiotropium in Russia. Therefore, the objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 µg tiotropium inhalation capsules) delivered by HandiHaler®, in a national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in a real life setting over the 8 weeks.

Detailed Description
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The objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 µg tiotropium inhalation capsules) delivered by HandiHaler®, in national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in the real life setting over the 8 weeks. Study Hypothesis: Primary interest is given to observe change from baseline in post-dose FEV1 after 8 weeks. Comparison(s): The objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 mcg tiotropium inhalation capsules) delivered by HandiHaler®, in national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in a real life setting over the 8 weeks.

Official Title
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RUSSE / Russian Spiriva® Safety & Efficacy Study

Conditions
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COPD

Intervention / Treatment
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* Drug: tiotropium-bromide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 years and older male and female ambulatory outpatients being seen in a participating physicians office for routine care Patients not previously treated with the Tiotropium Patients with clinical diagnosis of all stages of Chronic Obstructive Pulmonary Disease according to the current National Guidelines / 2004 Current smokers or ex-smokers with a smoking history of >=10 pack years Exclusion Criteria: Uncooperative patients as judged by the physician, Patients that have any condition which, according to the participating physicians opinion, might decrease the chance of obtaining satisfactory data to achieve the objectives of the observation, Patients with history of known preexisting or concomitant non-obstructive lung disease (e.g., sarcoidosis, tuberculosis, lung cancer), Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems, Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva®'s Russian package insert, such as: Patients with known narrow-angle glaucoma, Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction, Patient with known moderate to severe renal impairment (creatinine clearance less than 50 ml/min), Patients with a history of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium or to any component of this product, Pregnant or nursing women.

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

| Intervention/Treatment |
| --- |
|Drug: tiotropium-bromide|Spiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks | Forced expiratory volume in 1 second (FEV1) post-dose response at the end of the observation (Visit 3/week 8) versus (vs.) baseline (Visit 1/week 0) | baseline and final visit (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline for Forced Vital Capacity After 8 Weeks | Forced vital capacity (FVC) post-dose response at end of the observation (Visit 3/week 8 ) vs. baseline (Visit 1/week 0) | baseline and final visit (8 weeks) | 
| Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks | Inspiratory capacity (IC) post-dose response at end of the observation (Visit 3/week 8) vs. baseline (Visit 1/week 0) at selected sites | Visit 1 to Visit 3 (baseline and 8 weeks) | 
| Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS) | Patient Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8). | final visit (8 weeks) | 
| Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | Patient Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8). | final visit (8 weeks) | 
| Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS | Physician Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8). | final visit (8 weeks) | 
| Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | Physician Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8). | final visit (8 weeks) |