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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tiotropium
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 205.440.1006 Boehringer Ingelheim Investigational Site
  • 205.440.1015 Boehringer Ingelheim Investigational Site
  • 205.440.1002 Boehringer Ingelheim Investigational Site
  • 205.440.1018 Boehringer Ingelheim Investigational Site
  • 205.440.1008 Boehringer Ingelheim Investigational Site
  • 205.440.1017 Boehringer Ingelheim Investigational Site
  • 205.440.1020 Boehringer Ingelheim Investigational Site
  • 205.440.1011 Boehringer Ingelheim Investigational Site
  • 205.440.1019 Boehringer Ingelheim Investigational Site
  • 205.440.1013 Boehringer Ingelheim Investigational Site
  • 205.440.1007 Boehringer Ingelheim Investigational Site
  • 205.440.2003 Boehringer Ingelheim Investigational Site
  • 205.440.2001 Boehringer Ingelheim Investigational Site
  • 205.440.2004 Boehringer Ingelheim Investigational Site
  • 205.440.2002 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

18 mcg tiotropium

Placebo

Control

Arm Description

Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler

Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler

Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD

Outcomes

Primary Outcome Measures

Change From Baseline in Inspiratory Capacity (IC) at Isotime
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.

Secondary Outcome Measures

Constant Work Rate (CWR) Endurance Time
CWR exercise duration calculated as the length of time of the exercise period
Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime
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).

Full Information

First Posted
February 19, 2010
Last Updated
November 27, 2013
Sponsor
Boehringer Ingelheim
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01072396
Brief Title
Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
Collaborators
Pfizer

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18 mcg tiotropium
Arm Type
Active Comparator
Arm Description
Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
Arm Title
Control
Arm Type
No Intervention
Arm Description
Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
double blind randomized crossover
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
inhalation powder capsule identical to those containing tiotropium bromide inhalation powder
Primary Outcome Measure Information:
Title
Change From Baseline in Inspiratory Capacity (IC) at Isotime
Description
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.
Time Frame
baseline, six weeks of treatment
Secondary Outcome Measure Information:
Title
Constant Work Rate (CWR) Endurance Time
Description
CWR exercise duration calculated as the length of time of the exercise period
Time Frame
six weeks of treatment
Title
Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime
Description
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).
Time Frame
baseline, six weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
205.440.1006 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
205.440.1015 Boehringer Ingelheim Investigational Site
City
Jasper
State/Province
Alabama
Country
United States
Facility Name
205.440.1002 Boehringer Ingelheim Investigational Site
City
Torrance
State/Province
California
Country
United States
Facility Name
205.440.1018 Boehringer Ingelheim Investigational Site
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
205.440.1008 Boehringer Ingelheim Investigational Site
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
205.440.1017 Boehringer Ingelheim Investigational Site
City
Muncie
State/Province
Indiana
Country
United States
Facility Name
205.440.1020 Boehringer Ingelheim Investigational Site
City
Livonia
State/Province
Michigan
Country
United States
Facility Name
205.440.1011 Boehringer Ingelheim Investigational Site
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
205.440.1019 Boehringer Ingelheim Investigational Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
205.440.1013 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
205.440.1007 Boehringer Ingelheim Investigational Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
205.440.2003 Boehringer Ingelheim Investigational Site
City
Kingston
State/Province
Ontario
Country
Canada
Facility Name
205.440.2001 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
205.440.2004 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
205.440.2002 Boehringer Ingelheim Investigational Site
City
Ste-Foy
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26775292
Citation
Porszasz J, Blonshine S, Cao R, Paden HA, Casaburi R, Rossiter HB. Biological quality control for cardiopulmonary exercise testing in multicenter clinical trials. BMC Pulm Med. 2016 Jan 16;16:13. doi: 10.1186/s12890-016-0174-8.
Results Reference
derived
PubMed Identifier
25906326
Citation
Gagnon P, Casaburi R, Saey D, Porszasz J, Provencher S, Milot J, Bourbeau J, O'Donnell DE, Maltais F. Cluster Analysis in Patients with GOLD 1 Chronic Obstructive Pulmonary Disease. PLoS One. 2015 Apr 23;10(4):e0123626. doi: 10.1371/journal.pone.0123626. eCollection 2015.
Results Reference
derived
PubMed Identifier
25289942
Citation
Casaburi R, Maltais F, Porszasz J, Albers F, Deng Q, Iqbal A, Paden HA, O'Donnell DE; 205.440 Investigators. Effects of tiotropium on hyperinflation and treadmill exercise tolerance in mild to moderate chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Nov;11(9):1351-61. doi: 10.1513/AnnalsATS.201404-174OC.
Results Reference
derived
PubMed Identifier
24788342
Citation
O'Donnell DE, Maltais F, Porszasz J, Webb KA, Albers FC, Deng Q, Iqbal A, Paden HA, Casaburi R; 205.440 investigators. The continuum of physiological impairment during treadmill walking in patients with mild-to-moderate COPD: patient characterization phase of a randomized clinical trial. PLoS One. 2014 May 1;9(5):e96574. doi: 10.1371/journal.pone.0096574. eCollection 2014.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.440_U12-3606-01.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.440_Literature.pdf
Description
Related Info

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

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