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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072396
• Other study ID #: 205.440
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2010
• Last updated: November 27, 2013
• Start date: February 2010
• Est. completion date: November 2011

Study information

• Verified date: April 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium
double blind randomized crossover
• Placebo
inhalation powder capsule identical to those containing tiotropium bromide inhalation powder

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, six weeks of treatment	No
Secondary	Constant Work Rate (CWR) Endurance Time	CWR exercise duration calculated as the length of time of the exercise period	six weeks of treatment	No
Secondary	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).	baseline, six weeks of treatment	No

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