RUSSE / Russian Spiriva® Safety & Efficacy Study

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.

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.