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OpenTrials
Completed

NCT Number: NCT02579772

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

N-acetylcysteine

Drug

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.

Other names: NAC pills

Placebo

Drug

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

Other names: Placebo pills

Primary outcomes

  1. Plasma Redox Status - Circulating Glutathione

    Time frame: pre-exercise value (day 4)

    Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

  2. Exercise Capacity - Time to Exhaustion

    Time frame: end-exercise value (Day 4)

    Cycling time to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

Secondary outcomes

  1. Change in Central Cardiovascular Function - Cardiac Output

    Time frame: end-exercise value (Day 4)

    During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

  2. Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time)

    Time frame: Day 4

    Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

  3. Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time)

    Time frame: Day 4

    Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

  4. Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time)

    Time frame: Day 4

    Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

  5. Change in Pulmonary Ventilation - Minute Ventilation (VE)

    Time frame: end-exercise value (Day 4)

    During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2015
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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