Chronic Obstructive Pulmonary DiseasePhase 3NCT03956888
The Anti-oxidant Effects of N-Acetylcysteine in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing N-acetylcysteine in people with Chronic Obstructive Pulmonary Disease, run by Siriraj Hospital at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- N-acetylcysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2019to 30 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 9Show fewer
- Could not provide adequate sputum specimens
- Develop worsening of COPD symptoms during sputum induction
- Could not provide informed consent
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: The Effects of N-Acetylcysteine on Oxidative Stress Markers in Chronic Obstructive Pulmonary Disease (COPD)
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.
Read more
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
- Being tested
- N-acetylcysteine
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: N-acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (5)
Percentage of Neutrophil in sputum
To measure the number of Neutrophil in sputum before and after treated with NAC long in patients in this study, Reduce from first measurement.
Total cell counts are recorded with on a hemocytometer, using Kimura staining. Cell viability is determined by Trypan blue exclusion before cytospins were undertaken. The slides are stained with May-Grunwald-Giemsa stain and differential cell counts were made by a blinded observer. Four hundred inflammatory cells are counted on two slides for each sample in a blinded manner. Differential cell counts are expressed as the percentages of total Neutrophil will be reported.
Samples with cell viability of greater than 70% and less than 30% squamous cell contamination are considered adequate for analysis.
Measured: 4 weeks
FVC
To measure the FVC with Spirometry before and after treated with NAC long in patients in this study, improve from first measurement in FVC will be reported.
Measured: 4 weeks
FEV1
To measure the FEV1 with Spirometry before and after treated with NAC long in patients in this study, improve from first measurement in FEV1 will be reported.
Measured: 4 weeks
FEV1/FVC
To measure the FEV1/FVC with Spirometry before and after treated with NAC long in patients in this study, improve from first measurement in FEV1/FVC will be reported.
Measured: 4 weeks
COPD Assessment Test (CAT TM)
To measure the COPD Assessment Test (CATTM) before and after treated with NAC long in patients in this study.
CATTM is Patient-completed questionnaire assessing globally the impact of COPD (cough, sputum, dyspnea, chest tightness) on health status of COPD patient.
The minimum score is Zero (0) and the maximum score is Forty (40). Please see the correlation of score and impact level as in below table.
CAT score
Impact level
>30 = Very high
>20 = High
10-20 = Medium
<10 = Low
5 = -
In each question, there are score from 0 to five, the higher values represent the worse current situation. Score from each question will be summed then interpret based on CATTM Healthcare Professional User Guide ,Reduce test score from first measurement will be reported.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 May 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post study
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kittipong Maneechotesuwan, Siriraj Hospital
- Investigators
- Kittipong Maneechotesuwan, MD., PhD., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956888
- Sponsor's protocol ID
- TH_IIS_NAC_2018
- Status last verified
- Mar 2025
- First submitted
- 7 Jun 2018
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of N-Acetylcysteine on Oxidative Stress Markers in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03956888
- Acronym / sponsor ID
- TH_IIS_NAC_2018
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post study
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine treatment | Experimental | Drug: N-acetylcysteineAll 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 |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteineAll 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 treatment |
Primary outcome
Level of 8 - isoprostane, MDA and DNA damage in sputum
Time frame: 4 weeks
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.
5 secondary outcomes
Percentage of Neutrophil in sputum
Time frame: 4 weeks
FVC
Time frame: 4 weeks
FEV1
Time frame: 4 weeks
FEV1/FVC
Time frame: 4 weeks
COPD Assessment Test (CAT TM)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kittipong Maneechotesuwan, MD., PhD. principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-acetylcysteine in people with Chronic Obstructive Pulmonary Disease, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of 8 - isoprostane, MDA and DNA damage in sputum (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.