Status:
COMPLETED
RUSSE / Russian Spiriva® Safety & Efficacy Study
Lead Sponsor:
Boehringer Ingelheim
Conditions:
COPD
Eligibility:
All Genders
40+ years
Brief 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 bronc...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00613574
End Date
October 1 2007
Last Update
April 10 2014
Active Locations (33)
Enter a location and click search to find clinical trials sorted by distance.
1
Boehringer Ingelheim Investigational Site
Barnaul, Russia
2
Boehringer Ingelheim Investigational Site
Chelyabinsk, Russia
3
Boehringer Ingelheim Investigational Site
Irkutsk, Russia
4
Boehringer Ingelheim Investigational Site
Kazan', Russia