NCT03956888CompletedPhase 3
The Anti-oxidant Effects of N-Acetylcysteine in Chronic Obstructive Pulmonary Disease (COPD)
The Effects of N-Acetylcysteine on Oxidative Stress Markers in Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov · Last updated 14 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 7 Jun 2018
- Start date
- 1 May 2019
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Siriraj Hospital
- Diseases
- COPD
- NCT number
- NCT03956888
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 35
- From 1 May 2019 to the primary completion date, 30 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant with active and old pulmonary TB, lung cancer, bronchiectasis, lung fibrosis, destroyed lung and other malignancies
Other illness
- Recent acute coronary syndrome (within 12 weeks)
- Cerebrovascular disease without neurological recovery
- Cognitive impairment
- Recent respiratory viral infection (within 4 weeks)
Other
- Recent acute exacerbation of COPD (within 4 weeks)
- Could not provide adequate sputum specimens
- Develop worsening of COPD symptoms during sputum induction
- Could not provide informed consent
Who the study is looking for
- 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)
Age in the registry: 40 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.