The Anti-oxidant Effects of N-Acetylcysteine in Chronic Obstructive Pulmonary Disease (COPD)

NCT03956888 | Completed Phase 3

• 1 other identifier: TH_IIS_NAC_2018
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a condition defined as a disease state characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of lungs to noxious particles or gases, primarily caused by cigarette smoking. The accelerated decline in lung function is closely associated with an increased number of neutrophils in the sputum and hence with higher level of airway inflammation. It becomes clear that the inflammatory process potentiates as COPD progresses and exerts damage which is irreversible. Oxidative stress is inextricably linked to the inflammatory response. There is increasing evidence that an oxidant/antioxidant imbalance, in favor of oxidants, occurs in COPD. NAC has been reported to reduce the viscosity of sputum in both cystic fibrosis and COPD, facilitating the removal of pulmonary secretions. Moreover, by maintaining the airway clearance, it prevents bacterial stimulation of mucin production and hence mucus hypersecretion. The superiority of NAC over the other mucolytics may be in its anti-inflammatory and antioxidant properties and its mucolytic actions. The aim of this study is to evaluate the effects of treatment with NAC long on oxidative stress marker change and also explore the effect of NAC to airway inflammatory, lung function test and CAT scores. Selected oxidative stress marker was defined as 8 - isoprostane, protein carbonyl, DNA damage.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Level of 8 - isoprostane, MDA and DNA damage in sputum

  To measure the different level of 8 - isoprostane, MDA and DNA damage in sputum before and after treated with NAC long in patients in this study, Reduce from first measurement. The level of 8 - isoprostane, MDA and DNA damage are reported according to ELISA based on the manufacturer's instructions.

  4 weeks

Secondary Outcomes (5)

• Percentage of Neutrophil in sputum

  4 weeks

• FVC

  4 weeks

• FEV1

  4 weeks

• FEV1/FVC

  4 weeks

• COPD Assessment Test (CAT TM)

  4 weeks

Study Arms (1)

N-acetylcysteine treatment

EXPERIMENTAL

All COPD patients will be treated with N-acetylcysteine at the dose of 1200 mg per day (600 mg three times a day) for 4 weeks in addition to their current COPD medications without other mucolytic agents

Drug: N-acetylcysteine

Interventions

N-acetylcysteine DRUG

All COPD patients will be treated with N-acetylcysteine at the dose of 1200 mg per day (600 mg three times a day) for 4 weeks in addition to their current COPD medications without other mucolytic agents

N-acetylcysteine treatment

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible stable COPD patients who are currently treated with only short-acting bronchodilator (salbutamol or fenoterol/ipratropium bromide) or long-acting bronchodilator (LABA or LAMA) or inhaled corticosteroids/LABA
• Pre-bronchodilator FEV1 ≥ 80% and \< 80% predicted
• Current or ex-smokers (≥ 10 pack year)

You may not qualify if:

• Concomitant with active and old pulmonary TB, lung cancer, bronchiectasis, lung fibrosis, destroyed lung and other malignancies
• Recent acute coronary syndrome (within 12 weeks)
• Cerebrovascular disease without neurological recovery
• Cognitive impairment
• Recent acute exacerbation of COPD (within 4 weeks)
• Recent respiratory viral infection (within 4 weeks)
• Could not provide adequate sputum specimens
• Develop worsening of COPD symptoms during sputum induction
• Could not provide informed consent

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

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

Study Officials

• Kittipong Maneechotesuwan, MD., PhD.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pre-post study

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: May 21, 2019
• Study Start: May 1, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

TH (1)