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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
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 15, 2015
    Last Updated
    May 15, 2018
    Sponsor
    Queen's University
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    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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