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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00613574 |
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 ?g 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.
Condition | Intervention | Phase |
COPD |
Drug: tiotropium-bromide |
Phase IV |
Drug Information available for: | Tiotropium Tiotropium bromide |
Study Type: | Observational |
Official Title: | RUSSE / Russian Spiriva Safety & Efficacy Study |
Estimated Enrollment: | 400 |
Estimated Study Completion Date: | October 2007 |
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 hronic 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 the real life setting over the 8 weeks.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
S-Petersburg, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Moscow Region, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Yaroslavl, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
N. Novgorod, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Novosibirsk, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Krasnoyarsk, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Irkutsk, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Kemerovo, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Barnaul, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Vladivostok, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Rostov-on-Don, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Krasnodar, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Krasnodar region, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Kursk, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Ekaterinburg, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Chelyabinsk, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Voroneg, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Kazan, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Moscow, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Mezjdurechensk, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Ryazan, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Stavropol region, North Ossetia, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Tomsk, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Ufa, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
North Ossetia, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Omsk, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Khabarovsk, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Perm, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Samara, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Saratov, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Volgograd, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Stavropol, Russian Federation | |||||
Boehringer Ingelheim Investigational Site | |||||
Tyumen, Russian Federation |
Boehringer Ingelheim Pharmaceuticals |
Study Chair: | Boehringer Ingelheim Study Coordinator | BI Pharma Ges mbH Wien |
Study ID Numbers: | 205.396 |
First Received: | January 31, 2008 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00613574 |
Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation |
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