Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease

November 27, 2013 updated by: Boehringer Ingelheim

A Randomized, Double-blind, Placebo-controlled, 6-week, Crossover Study to Examine the Effects of Tiotropium (Spiriva® HandiHaler®, 18 µg Once Daily) on Dynamic Hyperinflation and Physical Exercise Capacity in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD)

Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada
        • 205.440.2003 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal, Quebec, Canada
        • 205.440.2001 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, Canada
        • 205.440.2004 Boehringer Ingelheim Investigational Site
      • Ste-Foy, Quebec, Canada
        • 205.440.2002 Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • 205.440.1006 Boehringer Ingelheim Investigational Site
      • Jasper, Alabama, United States
        • 205.440.1015 Boehringer Ingelheim Investigational Site
    • California
      • Torrance, California, United States
        • 205.440.1002 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States
        • 205.440.1018 Boehringer Ingelheim Investigational Site
    • Illinois
      • Springfield, Illinois, United States
        • 205.440.1008 Boehringer Ingelheim Investigational Site
    • Indiana
      • Muncie, Indiana, United States
        • 205.440.1017 Boehringer Ingelheim Investigational Site
    • Michigan
      • Livonia, Michigan, United States
        • 205.440.1020 Boehringer Ingelheim Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • 205.440.1011 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • 205.440.1019 Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • 205.440.1013 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Spartanburg, South Carolina, United States
        • 205.440.1007 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

For COPD subjects: Male or female, age of 40 years or older, smoking history >10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio <70%., FEV1 >/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.

Exclusion criteria:

Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.

Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.

Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 18 mcg tiotropium
Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
Drug: Tiotropium
double blind randomized crossover
Placebo Comparator: Placebo
Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
Drug: Placebo
inhalation powder capsule identical to those containing tiotropium bromide inhalation powder
No Intervention: Control
Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Inspiratory Capacity (IC) at Isotime
Time Frame: baseline, six weeks of treatment
Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline). Isotime is the minimum exercise time among all tests. Constant work rate exercise means the exercise is done under constant work rate.
baseline, six weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constant Work Rate (CWR) Endurance Time
Time Frame: six weeks of treatment
CWR exercise duration calculated as the length of time of the exercise period
six weeks of treatment
Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime
Time Frame: baseline, six weeks of treatment
Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).
baseline, six weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria

February 19, 2010

First Posted (Estimate)

February 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 24, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205.440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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