ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
RUSSE / Russian Spiriva Safety & Efficacy Study

This study has been completed.

Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00613574
  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 ?g 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.


Condition Intervention Phase
COPD
Drug: tiotropium-bromide
Phase IV

Drug Information available for:   Tiotropium    Tiotropium bromide   

U.S. FDA Resources

Study Type:   Observational
Official Title:   RUSSE / Russian Spiriva Safety & Efficacy Study

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary endpoint is FEV1 postdose response at Visit 3/week 8 (Day 58?2), end of the observation, vs. baseline (Visit 1/week 0 (Day 1 / baseline). [ Time Frame: 8 Weeks ]

Secondary Outcome Measures:
  • FVC postdose response at week 8 vs. baseline [ Time Frame: 8 Weeks ]
  • IC postdose response at week 8 vs. baseline on the selected Sites [ Time Frame: 8 weeks ]
  • Patient Global Assessment of efficacy and tolerability with 4 point scale symptoms at V3 [ Time Frame: 8 weeks ]
  • Physician Global Assessment [ Time Frame: 8 weeks ]

Estimated Enrollment:   400
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 mcg tiotropium inhalation capsules) delivered by HandiHaler, in national sample of Russian patients with varying severities of hronic 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 the 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

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 prior treated with the Tiotropium
  3. Patients with clinical diagnosis of all stages of Chronic Obstructive Pulmonary Disease according to the current National Guidelines / 2004,2
  4. Current smokers or ex-smokers with a smoking history 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 Spirivas 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

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

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

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals

Investigators
Study Chair:     Boehringer Ingelheim Study Coordinator     BI Pharma Ges mbH Wien    
  More Information


Study ID Numbers:   205.396
First Received:   January 31, 2008
Last Updated:   February 12, 2008
ClinicalTrials.gov Identifier:   NCT00613574
Health Authority:   Russia: Ministry of Health and Social Development of the Russian Federation

Study placed in the following topic categories:
Bromides
Tiotropium

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

ClinicalTrials.gov processed this record on October 23, 2008




Links to all studies - primarily for crawlers