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

Q

Queen's University

Status and phase

Completed
Phase 4

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: N-acetylcysteine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02579772
6015083

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

13 participants in 2 patient groups, including a placebo group

N-acetylcysteine
Active Comparator group
Description:
Pharmacological treatment with N-acetylcysteine (NAC) pills
Treatment:
Drug: N-acetylcysteine
Placebo
Placebo Comparator group
Description:
Treatment with placebo pills
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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