Study Results
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View full resultsBasic Information
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COMPLETED
407 participants
OBSERVATIONAL
2007-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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tiotropium-bromide
Spiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
BI Pharma Ges mbH Wien
Locations
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Boehringer Ingelheim Investigational Site
Barnaul, , Russia
Boehringer Ingelheim Investigational Site
Chelyabinsk, , Russia
Boehringer Ingelheim Investigational Site
Irkutsk, , Russia
Boehringer Ingelheim Investigational Site
Kazan', , Russia
Boehringer Ingelheim Investigational Site
Kemerovo, , Russia
Boehringer Ingelheim Investigational Site
Khabarovsk, , Russia
Boehringer Ingelheim Investigational Site
Krasnodar, , Russia
Boehringer Ingelheim Investigational Site
Krasnodar Region, , Russia
Boehringer Ingelheim Investigational Site
Krasnoyarsk, , Russia
Boehringer Ingelheim Investigational Site
Kursk, , Russia
Boehringer Ingelheim Investigational Site
Mezjdurechensk, , Russia
Boehringer Ingelheim Investigational Site
Moscow, , Russia
Boehringer Ingelheim Investigational Site
Moscow Region, , Russia
Boehringer Ingelheim Investigational Site
Nizhny Novgorod, , Russia
Boehringer Ingelheim Investigational Site
North Ossetia, , Russia
Boehringer Ingelheim Investigational Site
Novosibirsk, , Russia
Boehringer Ingelheim Investigational Site
Omsk, , Russia
Boehringer Ingelheim Investigational Site
Perm, , Russia
Boehringer Ingelheim Investigational Site
Rostov-on-Don, , Russia
Boehringer Ingelheim Investigational Site
Ryazan, , Russia
Boehringer Ingelheim Investigational Site
S-Petersburg, , Russia
Boehringer Ingelheim Investigational Site
Samara, , Russia
Boehringer Ingelheim Investigational Site
Saratov, , Russia
Boehringer Ingelheim Investigational Site
Stavropol, , Russia
Boehringer Ingelheim Investigational Site
Stavropol Region, North Ossetia, , Russia
Boehringer Ingelheim Investigational Site
Tomsk, , Russia
Boehringer Ingelheim Investigational Site
Tyumen, , Russia
Boehringer Ingelheim Investigational Site
Ufa, , Russia
Boehringer Ingelheim Investigational Site
Vladivostok, , Russia
Boehringer Ingelheim Investigational Site
Volgograd, , Russia
Boehringer Ingelheim Investigational Site
Voroneg, , Russia
Boehringer Ingelheim Investigational Site
Yaroslavl, , Russia
Boehringer Ingelheim Investigational Site
Yekaterinburg, , Russia
Countries
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Other Identifiers
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205.396
Identifier Type: -
Identifier Source: org_study_id
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