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

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ClinicalTrials.gov Identifier: NCT02579772
Recruitment Status : Completed
First Posted : October 20, 2015
Results First Posted : June 14, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. J. Alberto Neder, Queen's University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: N-acetylcysteine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Systemic Vascular Dysfunction in COPD Patients With Mild-to-moderate Airflow Obstruction: Pharmacological Treatment With N-acetylcysteine
Study Start Date : July 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: N-acetylcysteine
Pharmacological treatment with N-acetylcysteine (NAC) pills
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.
Other Name: NAC pills

Placebo Comparator: Placebo
Treatment with placebo pills
Drug: 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.
Other Name: Placebo pills




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579772


Sponsors and Collaborators
Queen's University
Investigators
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Principal Investigator: J. Alberto Neder, MD, PhD Queen's University

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Responsible Party: Dr. J. Alberto Neder, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT02579772     History of Changes
Other Study ID Numbers: 6015083
First Posted: October 20, 2015    Key Record Dates
Results First Posted: June 14, 2018
Last Update Posted: June 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Acetylcysteine
N-monoacetylcystine
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes