Effects of N-acetylcysteine on Cardiorespiratory Control in COPD Patients With Mild-to-moderate Airflow Obstruction

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Systemic Vascular Dysfunction in COPD Patients With Mild-to-moderate Airflow Obstruction: Pharmacological Treatment With N-acetylcysteine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579772
• Other study ID #: 6015083
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2018
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• N-acetylcysteine
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.
• Placebo
Placebo: 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Redox Status - Circulating Glutathione	Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine)	pre-exercise value (day 4)
Primary	Exercise Capacity - Time to Exhaustion	Cycling time to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)	end-exercise value (Day 4)
Secondary	Change in Central Cardiovascular Function - Cardiac Output	During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)	end-exercise value (Day 4)
Secondary	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)	Day 4
Secondary	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)	Day 4
Secondary	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)	Day 4
Secondary	Change in Pulmonary Ventilation - Minute Ventilation (VE)	During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)	end-exercise value (Day 4)