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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01072396
First received: February 19, 2010
Last updated: November 27, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change From Baseline in Inspiratory Capacity (IC) at Isotime [ Time Frame: baseline, six weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: six weeks of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, six weeks of treatment ] [ Designated as safety issue: No ]
    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).


Enrollment: 126
Study Start Date: February 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01072396

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

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01072396     History of Changes
Other Study ID Numbers: 205.440
Study First Received: February 19, 2010
Results First Received: November 22, 2012
Last Updated: November 27, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014