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Status:

COMPLETED

Pilot Study Comparing Tiotropium (Spiriva) to Salmeterol (Serevent) Plus Fluticasone (Flixotide) in Chronic Obstructive Pulmonary Disease (COPD)

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Pulmonary Disease, Chronic Obstructive

Eligibility:

All Genders

40+ years

Phase:

PHASE4

Brief Summary

The primary objective of this study is to estimate the comparative bronchodilator effect size and variability for tiotropium (Spiriva, 18 µg q.d.) with the free combination of salmeterol (Serevent, 50...

Detailed Description

This is a six-week, multi-centre, randomised, double-blind, triple-dummy, parallel group pilot study to compare the bronchodilator efficacy and safety of the long-acting bronchodilator tiotropium (Spi...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • All patients must have a diagnosis of chronic obstructive pulmonary disease according to the GOLD criteria and must meet the following spirometric criteria:
  • Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 \< 80% of predicted normal and FEV1/FVC \< 70% at Visit 1, and a pre-dose FEV1 \< 65% predicted at Visit 2.
  • Male or female patients 40 years of age or older. There is no upper age limit.
  • Patients must be current or ex-smokers with a smoking history of more than 10 pack-years.
  • Exclusion criteria:
  • Patients with significant diseases other than COPD.
  • Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count more than or equal to 600/mm3.
  • Patients who have been treated with commercially available tiotropium (Spiriva®).

Exclusion

    Key Trial Info

    Start Date :

    September 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    August 1 2004

    Estimated Enrollment :

    107 Patients enrolled

    Trial Details

    Trial ID

    NCT00239499

    Start Date

    September 1 2003

    End Date

    August 1 2004

    Last Update

    November 11 2013

    Active Locations (12)

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

    Page 1 of 3 (12 locations)

    1

    Tijger Trial Centre

    Bellville, South Africa, 7530

    2

    Boehringer Ingelheim Investigational Site

    Bloemfontein, South Africa, 9301

    3

    UCT Lung Institute

    Cape Town, South Africa, 7700

    4

    Boehringer Ingelheim Investigational Site

    Cape Town, South Africa, 8001