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

NCT ID: NCT03956888

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2024-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

N-acetylcysteine treatment

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

Group Type: EXPERIMENTAL

N-acetylcysteine

Intervention Type: 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

Interventions

N-acetylcysteine

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siriraj Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kittipong Maneechotesuwan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kittipong Maneechotesuwan, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

TH_IIS_NAC_2018

Identifier Type: -

Identifier Source: org_study_id