Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354354
Status:
COMPLETED
Last Update Posted:
2011-04-19
First Post:
2006-07-18
Brief Title:
Bronchodilators and Oxygen Kinetics With Exercise in Chronic Obstructive Pulmonary Disease COPD Patients
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
Bronchodilator Effect on O2 Deficit and VO2 Kinetics During Moderate Intensity Exercise in Normoxemic COPD
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypothesis The reduction of dynamic hyperinflation and its negative effects on the respiratory system following a bronchodilator could lead to an improvement of cardiac function in terms of increased cardiac output This may enhance oxygen delivery to the exercising muscles in COPD patients Bronchodilator administration may also have an indirect effect on VO2 kinetics via its action on cardiovascular and pulmonary variables
Objectives
1 To evaluate the effects of a bronchodilators on VE VCO2 and VO2 kinetics in COPD during constant work-rate cycle exercise and to evaluate whether bronchodilators will accelerate indirectly phase 2 kinetics usually slower in COPD patients than normal subjects and shorten t for VE VCO2 and VO2 and shorten half-times for HR and O2 pulse thus showing an improvement of oxygen transport to the peripheral active muscles
2 To determine the impact of a bronchodilator-induced reduction in dynamic hyperinflation and its effects on cardiovascular and pulmonary function on exercise limitation in COPD
Objectives
1 To evaluate the effects of a bronchodilators on VE VCO2 and VO2 kinetics in COPD during constant work-rate cycle exercise and to evaluate whether bronchodilators will accelerate indirectly phase 2 kinetics usually slower in COPD patients than normal subjects and shorten t for VE VCO2 and VO2 and shorten half-times for HR and O2 pulse thus showing an improvement of oxygen transport to the peripheral active muscles
2 To determine the impact of a bronchodilator-induced reduction in dynamic hyperinflation and its effects on cardiovascular and pulmonary function on exercise limitation in COPD
Detailed Description:
The inability to engage in the usual activities of daily living is one of the most distressing experiences of people afflicted with Chronic Obstructive Pulmonary Disease COPD Exercise intolerance progresses relentlessly as the disease advances and can lead to virtual immobility and social isolation Our understanding of the complex interface between physiological impairment and disability in COPD has increased considerably in recent years It has become clear that in COPD exercise intolerance ultimately reflects integrated abnormalities of the ventilatory cardiovascular peripheral muscle and neurosensory systems Ventilatory constraint is the dominant contributor to exercise limitation in more advanced disease Recently important studies have been conducted on the role of peripheral muscle dysfunction in exercise limitation in COPD
The present study will test the hypothesis that the administration of bronchodilators ie inhaled β2-agonist and inhaled anticholinergics in combination in normoxemic COPD patients during moderate-intensity constant-load exercise may result in an enhancement of oxidative metabolism reflected by reductions of O2 def and phase 2 tVO2
Fifteen normoxemic patients with stable COPD FEV1 less than 60 predicted and severe chronic breathlessness Baseline Dyspnea Index less than 6 will complete the study
Each patient will perform three visits At the first visit patients will be familiarized with the various questionnaires and scales for rating the intensity and quality of symptoms and they will carry out pulmonary function testing and a symptom-limited incremental cycle exercise test in order to determine the anaerobic threshold AT the peak work-rate and the peak oxygen uptake Each patient will subsequently complete two visits in which they will receive either nebulized bronchodilator BD Combivent ipratropium 05 mg salbutamol 25 mg or placebo PL in random order At 90-100 minutes post-dose patients will perform pulmonary function tests then they will perform a constant-load exercise test at 80 of AT VO2 During constant-load exercise tests 2nd and 3rd visit small samples of blood from the earlobe of each subject will be collected in order to determine the level of lactate and breathing gases oxygen and carbon dioxide in the blood
The present study will test the hypothesis that the administration of bronchodilators ie inhaled β2-agonist and inhaled anticholinergics in combination in normoxemic COPD patients during moderate-intensity constant-load exercise may result in an enhancement of oxidative metabolism reflected by reductions of O2 def and phase 2 tVO2
Fifteen normoxemic patients with stable COPD FEV1 less than 60 predicted and severe chronic breathlessness Baseline Dyspnea Index less than 6 will complete the study
Each patient will perform three visits At the first visit patients will be familiarized with the various questionnaires and scales for rating the intensity and quality of symptoms and they will carry out pulmonary function testing and a symptom-limited incremental cycle exercise test in order to determine the anaerobic threshold AT the peak work-rate and the peak oxygen uptake Each patient will subsequently complete two visits in which they will receive either nebulized bronchodilator BD Combivent ipratropium 05 mg salbutamol 25 mg or placebo PL in random order At 90-100 minutes post-dose patients will perform pulmonary function tests then they will perform a constant-load exercise test at 80 of AT VO2 During constant-load exercise tests 2nd and 3rd visit small samples of blood from the earlobe of each subject will be collected in order to determine the level of lactate and breathing gases oxygen and carbon dioxide in the blood
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None