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

NCT02579772 | Completed Phase 4 Results

• 1 other identifier: 6015083
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Plasma Redox Status - Circulating Glutathione

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

  pre-exercise value (day 4)

• Exercise Capacity - Time to Exhaustion

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

  end-exercise value (Day 4)

Secondary Outcomes (5)

• Change in Central Cardiovascular Function - Cardiac Output

  end-exercise value (Day 4)

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

  Day 4

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

  Day 4

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

  Day 4

• Change in Pulmonary Ventilation - Minute Ventilation (VE)

  end-exercise value (Day 4)

Study Arms (2)

N-acetylcysteine

ACTIVE COMPARATOR

Pharmacological treatment with N-acetylcysteine (NAC) pills

Drug: N-acetylcysteine

Placebo

PLACEBO COMPARATOR

Treatment with placebo pills

Drug: Placebo

Interventions

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.

Also known as: NAC pills

N-acetylcysteine

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.

Also known as: Placebo pills

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Queen's University: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. J. Alberto Neder
• Organization: Queen's University

nederalb@gmail.com

613-548-2255

Study Officials

• J. Alberto Neder, MD, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 20, 2015
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 14, 2018
• Results First Posted: June 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share