RUSSE / Russian Spiriva® Safety & Efficacy Study

Boehringer Ingelheim

Status: Completed

Conditions: COPD

Treatments: Drug: tiotropium-bromide

Study type: Observational

Funder types: Industry

Identifiers

NCT00613574

205.396

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 407 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.