Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effects of Dual Bronchodilator Treatment (Tiotropium + Olodaterol Respimat) on Cardiopulmonary Interactions in Hyperinflated Patients With COPD
Verified date | February 2019 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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, is strongly influenced by changes in lung volumes and intra-thoracic pressures. In this context, strategies to reduce lung hyperinflation and the work of breathing can positively impact upon cardiac output and blood flow redistribution to peripheral muscles in these patients. There is growing evidence that combination of bronchodilators of different classes is an efficacious and safe strategy for further improving airflow obstruction and hyperinflation in patients with more advanced COPD. Therefore, we aim to investigate that, compared with placebo, a novel LABA/LAMA fixed combination (tiotropium 5 mcg plus olodaterol 5 mcg via Respimat® (Inspiolto®) (TIO/OLO) would decrease lung volumes at rest and during exercise, thereby improving: 1) central and peripheral hemodynamics and 2) arterial oxygenation, with positive consequences on skeletal muscle oxygenation and exercise tolerance in hyperinflated patients with moderate to very severe COPD.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 100 Years |
Eligibility |
Inclusion Criteria: 1. Age =50 years; 2. Male or female gender; 3. Long-term history of active smoking; 4. Signs and symptoms of COPD with adequate treatment according to the GOLD recommendations for at least 3 months (1); 5. A modified MRC dyspnea score =2 or a Baseline Dyspnea Index =8; 6. Resting lung hyperinflation as demonstrated by inspiratory capacity <80% predicted or functional residual capacity >120% predicted at Visit 1; 7. 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; 8. A positive "volume" response (=200 mL increase in inspiratory capacity) to a bronchodilator (400µg salbutamol) at Visit 1 9. Ability to perform all study procedures and provide/sign informed consent. Exclusion Criteria: 1. Asthma or other concomitant pulmonary disease; 2. Use of oral steroids in the preceding month; 3. Orthopedic/rheumatological limitation precluded cycling; 4. Type I or non-controlled type II diabetes mellitus or other endocrine diseases; 5. Unstable angina, life-threatening cardiac arrhythmias, use of an implantable defibrillator; 6. Myocardial infarction within the previous 6 months; 7. History of long QT syndrome (or prolonged corrected QT interval (>450 ms during screening); 8. Clinically significant ECG abnormality; 9. History of exercise-induced syncope; 10. Any contraindication for exercise testing; 11. Inability to understand and cooperate with the procedures. |
Country | Name | City | State |
---|---|---|---|
Canada | Kingston General Hospital | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University | Boehringer Ingelheim |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood Flow Index (BFI) | Near infrared spectroscopy (NIRS)-derived muscle ICG difference divided by the rise time from 10 to 90% of peak. | 1 day | |
Secondary | Cardiac output | Cardiac output measured by thoracic cardioimpedance | 1 day | |
Secondary | Muscle oxygenation | Deoxy-hemoglobin (HHb) has been selected as a proxy for muscle fractional O2 extraction and expressed relative to maximum values elicited by cuff-induced ischemia. | 1 day | |
Secondary | Tlim | Exercise tolerance during hugh intensity constant load exercise test (75% of peak workload) | 1 day | |
Secondary | Exercise dyspnea | Borg score rated during isotime and peak exercise | 1 day | |
Secondary | Inspiratory capacity | Inspiratory capacity, inspiratory reserve volume measured at rest, isotime and peak exercise | 1 day | |
Secondary | Inspiratory reserve volume | Inspiratory reserve volume measured at rest, isotime and peak exercise | 1 day |
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