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Status:

COMPLETED

Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Asthma

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to s...

Eligibility Criteria

Inclusion

  • Inclusion\_Criteria:
  • Patients homozygous for arginine at the 16th amino acid position of the beta2 adrenergic receptor (B16 Arg/Arg)
  • All patients must sign and date an Informed Consent Form for the study prior to participation in the trial
  • Male or female outpatients with at least 18 years of age, but not older than 65 years
  • Patients must have a documented history of asthma
  • Patients must be current non-smokers or ex-smokers with a cigarette smoking history of \<10 pack-years
  • Patients must be on a maintenance treatment with inhaled corticosteroids with a total daily dose of 400 - 1000 mcg budesonide or equivalent
  • Exclusion\_Criteria:
  • Patients with a significant disease other than asthma
  • Patients with a recent history (i.e., six months or less) of myocardial infarction
  • Patients who have been hospitalized for heart failure (New York Heart Association class III or IV) within the past year
  • Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
  • Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
  • Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
  • Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
  • Patients with known active tuberculosis
  • Patients who have undergone thoracotomy with pulmonary resection.
  • Patients who have completed a pulmonary rehabilitation program in the six weeks prior to visit 1 or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study.

Exclusion

    Key Trial Info

    Start Date :

    July 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    388 Patients enrolled

    Trial Details

    Trial ID

    NCT00350207

    Start Date

    July 1 2006

    Last Update

    December 24 2013

    Active Locations (109)

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    Page 1 of 28 (109 locations)

    1

    205.342.43002 Boehringer Ingelheim Investigational Site

    Graz, Austria

    2

    205.342.43004 Boehringer Ingelheim Investigational Site

    Trofaiach, Austria

    3

    205.342.43001 Boehringer Ingelheim Investigational Site

    Vienna, Austria

    4

    205.342.43005 Boehringer Ingelheim Investigational Site

    Vienna, Austria