RUSSE / Russian Spiriva® Safety & Efficacy Study

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Bromides; Tiotropium Bromide

Criteria

Inclusion Criteria:

1. 40 years and older male and female ambulatory outpatients being seen in a participating physicians office for routine care

2. Patients not previously treated with the Tiotropium

3. Patients with clinical diagnosis of all stages of Chronic Obstructive Pulmonary Disease according to the current National Guidelines / 2004

4. Current smokers or ex-smokers with a smoking history of >=10 pack years

Exclusion Criteria:

1. Uncooperative patients as judged by the physician,

2. 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,

3. Patients with history of known preexisting or concomitant non-obstructive lung disease (e.g., sarcoidosis, tuberculosis, lung cancer),

4. Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems,

5. Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva®'s Russian package insert, such as:

6. Patients with known narrow-angle glaucoma,

7. Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction,

8. Patient with known moderate to severe renal impairment (creatinine clearance less than 50 ml/min),

9. Patients with a history of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium or to any component of this product,

10. Pregnant or nursing women.