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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

407

participants targeted

Target at P75+ for all trials

Geographic Reach

1 country

33 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed

13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

January 18, 2010

Completed

Last Updated

April 10, 2014

Status Verified

March 1, 2014

First QC Date

January 31, 2008

Results QC Date

October 29, 2009

Last Update Submit

March 12, 2014

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks
Forced expiratory volume in 1 second (FEV1) post-dose response at the end of the observation (Visit 3/week 8) versus (vs.) baseline (Visit 1/week 0)
baseline and final visit (8 weeks)

Secondary Outcomes (6)

Change From Baseline for Forced Vital Capacity After 8 Weeks
baseline and final visit (8 weeks)
Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks
Visit 1 to Visit 3 (baseline and 8 weeks)
Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS)
final visit (8 weeks)
Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS
final visit (8 weeks)
Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS
final visit (8 weeks)
+1 more secondary outcomes

Interventions

tiotropium-bromideDRUG

Spiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Physicians

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.