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

NCT ID: NCT02579772

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-05-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

N-acetylcysteine

Pharmacological treatment with N-acetylcysteine (NAC) pills

Group Type: ACTIVE_COMPARATOR

N-acetylcysteine

Intervention Type: 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.

Placebo

Treatment with placebo pills

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

NAC pills; Placebo pills

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. J. Alberto Neder

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Alberto Neder, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Other Identifiers

6015083

Identifier Type: -

Identifier Source: org_study_id