RUSSE / Russian Spiriva® Safety & Efficacy Study

March 12, 2014 updated by: Boehringer Ingelheim
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Actual)

407

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Barnaul, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Chelyabinsk, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Ekaterinburg, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Irkutsk, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Kazan, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Kemerovo, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Khabarovsk, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Krasnodar, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Krasnodar region, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Krasnoyarsk, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Kursk, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Mezjdurechensk, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Moscow, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Moscow Region, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • N. Novgorod, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • North Ossetia, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Novosibirsk, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Omsk, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Perm, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Rostov-on-Don, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Ryazan, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • S-Petersburg, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Samara, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Saratov, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Stavropol, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Stavropol region, North Ossetia, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Tomsk, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Tyumen, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Ufa, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Vladivostok, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Volgograd, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Voroneg, Russian Federation
        • Boehringer Ingelheim Investigational Site
      • Yaroslavl, Russian Federation
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Physicians

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks
Time Frame: baseline and final visit (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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline for Forced Vital Capacity After 8 Weeks
Time Frame: baseline and final visit (8 weeks)
Forced vital capacity (FVC) post-dose response at end of the observation (Visit 3/week 8 ) vs. baseline (Visit 1/week 0)
baseline and final visit (8 weeks)
Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks
Time Frame: Visit 1 to Visit 3 (baseline and 8 weeks)
Inspiratory capacity (IC) post-dose response at end of the observation (Visit 3/week 8) vs. baseline (Visit 1/week 0) at selected sites
Visit 1 to Visit 3 (baseline and 8 weeks)
Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS)
Time Frame: final visit (8 weeks)
Patient Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).
final visit (8 weeks)
Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS
Time Frame: final visit (8 weeks)
Patient Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).
final visit (8 weeks)
Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS
Time Frame: final visit (8 weeks)
Physician Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).
final visit (8 weeks)
Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS
Time Frame: final visit (8 weeks)
Physician Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy&tolerability, 4=poor) at end of the observation (Visit 3/week 8).
final visit (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, BI Pharma Ges mbH Wien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

October 1, 2007

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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