Clinical trial NCT02579772: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Plasma Redox Status - Circulating Glutathione
timeFrame: pre-exercise value (day 4)
measure: Exercise Capacity - Time to Exhaustion
timeFrame: end-exercise value (Day 4)
Secondary outcomes:
measure: Change in Central Cardiovascular Function - Cardiac Output
timeFrame: end-exercise value (Day 4)
measure: Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time)
timeFrame: Day 4
measure: Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time)
timeFrame: Day 4
measure: Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time)
timeFrame: Day 4
measure: Change in Pulmonary Ventilation - Minute Ventilation (VE)
timeFrame: end-exercise value (Day 4)
Other outcomes:
Locations:
Study officials:
affiliation: Queen's University
name: J. Alberto Neder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: