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OpenTrials
Completed

NCT Number: NCT00240435

12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD

The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boehringer Ingelheim Investigational Site, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60% predicted [ECCS criteria] and FEV1/FVC </= 70%)

Treatment and study plan

5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler

Device

10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler

Device

Primary outcomes

  1. Trough FEV1 response after 12 weeks of treatment.

    Time frame: after 12 weeks

Secondary outcomes

  1. Trough FEV1 response

    Time frame: after 1, 4 and 8 weeks

  2. Trough FVC response

    Time frame: after 1, 4, 8 and 12 weeks

  3. FEV1 and FVC area under the curve and peak response

    Time frame: after 0, 1, 4, 8 and 12 weeks

  4. Individual FEV1 and FVC measurements at each time point

    Time frame: during study course of 12 weeks

  5. Therapeutic response and percentage of responders

    Time frame: after 0 and 12 weeks

  6. Weekly mean pre-dose morning and evening PEFR

    Time frame: during study course of 12 weeks

  7. Number of occasions of rescue therapy used per day (PRN salbutamol)

    Time frame: during study course of 12 weeks

  8. COPD symptom scores

    Time frame: during 15 weeks

  9. Physician's Global Evaluation

    Time frame: during 15 weeks

  10. Number of patients with at least one exacerbation of COPD

    Time frame: 15 weeks

  11. time to first exacerbation

    Time frame: 15 weeks

  12. number of exacerbations

    Time frame: 15 weeks

  13. number of exacerbation days

    Time frame: 15 weeks

  14. Patient satisfaction and preference

    Time frame: 12 weeks

  15. All adverse events

    Time frame: during 15 weeks, follow-up period included

  16. Pulse rate and blood pressure for the first three hours following dosing

    Time frame: after 0, 1, 4, 8 and 12 weeks

  17. Routine blood chemistry, haematology and urinalysis

    Time frame: after 12 weeks

  18. 12-lead ECG

    Time frame: after 12 weeks

  19. Physical examination

    Time frame: after 12 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i

Important dates

Study start
2002
Primary completion
2003
First posted
Oct 18, 2005
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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