Clinical trial NCT03956888: The Anti-oxidant Effects of N-Acetylcysteine in Chronic Obstructive Pulmonary Disease (COPD)
Official title: The Effects of N-Acetylcysteine on Oxidative Stress Markers in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post study
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Level of 8 - isoprostane, MDA and DNA damage in sputum
timeFrame: 4 weeks
Secondary outcomes:
measure: Percentage of Neutrophil in sputum
timeFrame: 4 weeks
measure: FVC
timeFrame: 4 weeks
measure: FEV1
timeFrame: 4 weeks
measure: FEV1/FVC
timeFrame: 4 weeks
measure: COPD Assessment Test (CAT TM)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Siriraj Hospital
name: Kittipong Maneechotesuwan, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References: