RUSSE / Russian Spiriva® Safety & Efficacy Study

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00613574
First received: January 31, 2008
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
COPD
Drug: tiotropium-bromide
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: RUSSE / Russian Spiriva® Safety & Efficacy Study

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks [ Time Frame: baseline and final visit (8 weeks) ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Change From Baseline for Forced Vital Capacity After 8 Weeks [ Time Frame: baseline and final visit (8 weeks) ] [ Designated as safety issue: No ]
    Forced vital capacity (FVC) post-dose response at end of the observation (Visit 3/week 8 ) vs. baseline (Visit 1/week 0)

  • Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks [ Time Frame: Visit 1 to Visit 3 (baseline and 8 weeks) ] [ Designated as safety issue: No ]
    Inspiratory capacity (IC) post-dose response at end of the observation (Visit 3/week 8) vs. baseline (Visit 1/week 0) at selected sites

  • Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS) [ Time Frame: final visit (8 weeks) ] [ Designated as safety issue: No ]
    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).

  • Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS [ Time Frame: final visit (8 weeks) ] [ Designated as safety issue: No ]
    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).

  • Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS [ Time Frame: final visit (8 weeks) ] [ Designated as safety issue: No ]
    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).

  • Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS [ Time Frame: final visit (8 weeks) ] [ Designated as safety issue: No ]
    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).


Enrollment: 407
Estimated Study Completion Date: October 2007
Intervention Details:
    Drug: tiotropium-bromide
    Spiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Physicians

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613574

Locations
Russian Federation
Boehringer Ingelheim Investigational Site
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
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BI Pharma Ges mbH Wien
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00613574     History of Changes
Other Study ID Numbers: 205.396
Study First Received: January 31, 2008
Results First Received: October 29, 2009
Last Updated: March 12, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014