Effects of N-acetylcysteine on Cardiorespiratory Control in COPD Patients With Mild-to-moderate Airflow Obstruction
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
N-acetylcysteine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
- stable COPD with mild-to-moderate airflow obstruction as indicated by the low ratio between forced expiratory volume in one second and forced vital capacity (FEV1/FVC<0.7) together with post-bronchodilator FEV1≥60% predicted under optimized clinical treatment as judged by the accompanying physician
Exclusion Criteria:
- unable to perform all experimental procedures and/or provide informed consent;
- hospital admission in the previous 6 weeks;
- exercise training program in the previous 6 months;
- any condition that could interfere with the ability to exercise;
- diagnosed psychiatric or cognitive disorders;
- type I insulin-dependent diabetes mellitus;
- excessively over-weight (BMI>35kg/m²);
- other diagnosed cardiorespiratory disorders (e.g., chronic heart failure, peripheral artery disease).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
N-acetylcysteine
Placebo
Arm Description
Pharmacological treatment with N-acetylcysteine (NAC) pills
Treatment with placebo pills
Outcomes
Primary Outcome Measures
Plasma Redox Status - Circulating Glutathione
Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Exercise Capacity - Time to Exhaustion
Cycling time to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Secondary Outcome Measures
Change in Central Cardiovascular Function - Cardiac Output
During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time)
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time)
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time)
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Change in Pulmonary Ventilation - Minute Ventilation (VE)
During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02579772
Brief Title
Effects of N-acetylcysteine on Cardiorespiratory Control in COPD Patients With Mild-to-moderate Airflow Obstruction
Official Title
Systemic Vascular Dysfunction in COPD Patients With Mild-to-moderate Airflow Obstruction: Pharmacological Treatment With N-acetylcysteine
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to determine whether pharmacological treatment with N-acetylcysteine improves central and peripheral cardiorespiratory control and physical capacity in COPD patients with mild-to-moderate airflow obstruction.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Cardiovascular complications constitute the main causes of poor physical capacity and healthcare resources utilization in COPD. There is emerging evidence that these impairments have a major impact on the health of patients with mild-to-moderate disease, the largest sub-population of COPD. This important problem, however, is currently neglected as no specific pharmacological treatment is offered to these patients. Recent studies indicate that vascular abnormalities are mediated, at least in part, by circulating inflammatory substances and direct damage of the arteries by oxygen radicals (oxidative stress). The current investigation will test the hypothesis that N-acetylcysteine (NAC), via its anti-inflammatory and antioxidant properties, improves systemic vascular function and physical capacity in COPD patients with mild-to-moderate airflow obstruction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcysteine
Arm Type
Active Comparator
Arm Description
Pharmacological treatment with N-acetylcysteine (NAC) pills
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo pills
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
NAC pills
Intervention Description
Pharmacological treatment with N-acetylcysteine (NAC): 3 pills of 600 mg of NAC/day orally for 4 days prior to experimental procedures and 1 pill of 600 mg of NAC orally on the day of the experiment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo pills
Intervention Description
Placebo: 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Primary Outcome Measure Information:
Title
Plasma Redox Status - Circulating Glutathione
Description
Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Time Frame
pre-exercise value (day 4)
Title
Exercise Capacity - Time to Exhaustion
Description
Cycling time to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Time Frame
end-exercise value (Day 4)
Secondary Outcome Measure Information:
Title
Change in Central Cardiovascular Function - Cardiac Output
Description
During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Time Frame
end-exercise value (Day 4)
Title
Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time)
Description
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Time Frame
Day 4
Title
Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time)
Description
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Time Frame
Day 4
Title
Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time)
Description
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Time Frame
Day 4
Title
Change in Pulmonary Ventilation - Minute Ventilation (VE)
Description
During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Time Frame
end-exercise value (Day 4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable COPD with mild-to-moderate airflow obstruction as indicated by the low ratio between forced expiratory volume in one second and forced vital capacity (FEV1/FVC<0.7) together with post-bronchodilator FEV1≥60% predicted under optimized clinical treatment as judged by the accompanying physician
Exclusion Criteria:
unable to perform all experimental procedures and/or provide informed consent;
hospital admission in the previous 6 weeks;
exercise training program in the previous 6 months;
any condition that could interfere with the ability to exercise;
diagnosed psychiatric or cognitive disorders;
type I insulin-dependent diabetes mellitus;
excessively over-weight (BMI>35kg/m²);
other diagnosed cardiorespiratory disorders (e.g., chronic heart failure, peripheral artery disease).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Alberto Neder, MD, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of N-acetylcysteine on Cardiorespiratory Control in COPD Patients With Mild-to-moderate Airflow Obstruction
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