Status:
COMPLETED
Effects of Dual Bronchodilator Treatment on Cardiopulmonary Interactions in COPD
Lead Sponsor:
Queen's University
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
50-100 years
Phase:
PHASE4
Brief Summary
The deleterious consequences of lung hyperinflation seem not to be restricted to the respiratory system in patients with chronic obstructive pulmonary disease (COPD). Cardiac function, in particular, ...
Detailed Description
Prospective, proof-of-concept, single-dose study will be conducted using a randomized, double-blind, placebo-controlled, crossover design. Treatment will consist of a single dose of tiotropium 5mcg an...
Eligibility Criteria
Inclusion
- Age ≥50 years;
- Male or female gender;
- Long-term history of active smoking;
- Signs and symptoms of COPD with adequate treatment according to the GOLD recommendations for at least 3 months (1);
- A modified MRC dyspnea score ≥2 or a Baseline Dyspnea Index ≤8;
- Resting lung hyperinflation as demonstrated by inspiratory capacity \<80% predicted or functional residual capacity \>120% predicted at Visit 1;
- Objective evidence of dynamic hyperinflation (a decrease in inspiratory capacity from rest \>200 mL)(24,25) and peak exercise dyspnea (breathing discomfort) ≥ leg discomfort scores during the incremental cardiopulmonary exercise test at Visit 1;
- A positive "volume" response (≥200 mL increase in inspiratory capacity) to a bronchodilator (400μg salbutamol) at Visit 1
- Ability to perform all study procedures and provide/sign informed consent.
Exclusion
- Asthma or other concomitant pulmonary disease;
- Use of oral steroids in the preceding month;
- Orthopedic/rheumatological limitation precluded cycling;
- Type I or non-controlled type II diabetes mellitus or other endocrine diseases;
- Unstable angina, life-threatening cardiac arrhythmias, use of an implantable defibrillator;
- Myocardial infarction within the previous 6 months;
- History of long QT syndrome (or prolonged corrected QT interval (\>450 ms during screening);
- Clinically significant ECG abnormality;
- History of exercise-induced syncope;
- Any contraindication for exercise testing;
- Inability to understand and cooperate with the procedures.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03425617
Start Date
January 1 2017
End Date
June 30 2018
Last Update
February 5 2019
Active Locations (1)
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1
Kingston General Hospital
Kingston, Ontario, Canada, k7l2v7