Last reviewed · How we verify
NCT03956888
The Anti-oxidant Effects of N-Acetylcysteine in Chronic Obstructive Pulmonary Disease (COPD)
Phase 3 trial testing N-acetylcysteine in Chronic Obstructive Pulmonary Disease in 35 participants. Completed in 30 December 2024.
30 December 2023
Quick facts
| Lead sponsor | Siriraj Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 35 |
| Start date | 1 May 2019 |
| Primary completion | 30 December 2023 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- N-acetylcysteine — full drug profile →
Conditions studied
- Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →
Sponsor
Siriraj Hospital
Who can join
Adults 40 to 90, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Anti-oxidative stress treatment and current clinical trials.
Zhang CY, Yang M. · · 2024 · cited 3× · PMID 38495278 · DOI 10.4254/wjh.v16.i2.294
Verify or expand the search:
- PubMed search for NCT03956888
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of N-acetylcysteine
Trials testing the same drug.
- NCT05074121 — NAC for Attenuation of COVID-19 Symptomatology · Phase 2 · unknown
- NCT05494398 — Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Open Label · Phase 2, PHASE3 · enrolling by invitation
- NCT06236165 — Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of N-acetylcysteine Supplementation in Patients With · Phase 2 · completed
- NCT05706402 — N-acetylcysteine (NAC) for the Treatment of Acute Exacerbation of COPD · Phase 3 · unknown
- NCT00775476 — Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine · Phase 2 · recruiting
Other recruiting trials for Chronic Obstructive Pulmonary Disease
Currently open trials in the same condition.
- NCT06749262 — Inclined Versus Standard Exercise for COPD Patients · NA · recruiting
- NCT07406659 — Different Inspiratory Muscle Trainings in Patients With COPD · NA · recruiting
- NCT07051707 — Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD · NA · recruiting
- NCT07418736 — A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease · Phase 2 · recruiting
- NCT07069829 — Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo · recruiting
Other Siriraj Hospital trials
Trials by the same sponsor.
- NCT07262034 — The Impact of Preoperative Nutrition Intervention on Muscle Mass Preserve in Older Adults Undergoing Elective Surgery · not yet recruiting
- NCT07402486 — A Phase II Prospective Study of Maastro Applicator Brachytherapy for Rectal Cancer · Phase 2 · not yet recruiting
- NCT07298577 — Use of Gender, Age, Alfa-fetoprotein (AFP), and Des-gamma-carboxyprothrombin (PIVKA-II) or GAAD Score in Addition to Ult · NA · not yet recruiting
- NCT07239908 — Resuscitation Enhancement to Avoid Rearrest Through Evidence-based Strategies in Prehospital Post-resuscitation Care · Phase 2, PHASE3 · not yet recruiting
- NCT07110961 — The Suggested Immobilization Test With Exploratory Heart Rate Variability Analysis for Diagnosis of Restless Legs Syndro · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03956888 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Siriraj Hospital
- Last refreshed: 14 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03956888.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing