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Status:

COMPLETED

Tiotropium Respimat Pharmacokinetic Study in COPD

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Pulmonary Disease, Chronic Obstructive

Eligibility:

All Genders

40+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmaco...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • All patient must sign an informed consent consistent with IInternational Conference on Harmonisation- Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to any study-related procedures, including medication washout and restrictions.
  • Relatively stable, moderate to very severe Chronic Obstructive Pulmonary Disease (COPD)
  • Current or ex-smokers (smoking history of at least 10 pack years)
  • Able to perform lung function tests
  • Able to use study inhalers
  • Exclusion criteria:
  • Significant diseases other than COPD
  • Recent myocardial infarction, unstable or life-threatening cardiac arrhythmia, hospitalisation for cardiac failure.
  • Malignancy requiring resection, radiation therapy or chemotherapy within the last 5 years
  • History of asthma, life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis 5 Active tuberculosis
  • 6\. History of alcohol or drug abuse 7. Pulmonary resection 8. Recent completion of a pulmonary rehabilitation program or current participation which will not be continued 9. Daytime oxygen therapy for more than 1 hour per day. 10. Use of other investigational drugs, restrictions on the use of some respiratory medications during the study period.
  • 11\. Current participation in another clinical trial 12. Pregnant or nursing women 13. Women of childbearing potential not using a highly effective method of contraception (e.g: implants, injectable, oral contraceptives)

Exclusion

    Key Trial Info

    Start Date :

    October 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    154 Patients enrolled

    Trial Details

    Trial ID

    NCT01222533

    Start Date

    October 1 2010

    Last Update

    May 16 2014

    Active Locations (11)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (11 locations)

    1

    205.458.32003 Boehringer Ingelheim Investigational Site

    Genk, Belgium

    2

    205.458.32001 Boehringer Ingelheim Investigational Site

    Ghent, Belgium

    3

    205.458.32002 Boehringer Ingelheim Investigational Site

    Hasselt, Belgium

    4

    205.458.45001 Boehringer Ingelheim Investigational Site

    Copenhagen K, Denmark