A Phase 4 interventional study of N-acetycysteine (600mg twice daily) and Placebo in COPD, sponsored by Kwong Wah Hospital. Completed at 1 site in China. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-04-09.
Sponsored by Kwong Wah Hospital · Phase 4, Interventional, and Treatment
This study is to investigate the add-on effect of high dose NAC (600mg tablet twice daily) on reduction of airtrapping and airway resistance in stable COPD patients as well as to study it's effect in reducing exacerbation, improving exercise capacity and quality of life in stable COPD patients.
Background: The mucolytic and antioxidant effects of N-acetylcysteine (NAC) may be of great value in treatment of COPD patients. However, previous studies fail to demonstrate the beneficial effect of NAC. This may be due to insufficient dose of NAC used as well as inadequate outcome parameters measured in the past studies.
Objective of study: This study is to investigate the add-on effect of high dose NAC (600mg tablet twice daily) on reduction of airtrapping and airway resistance in stable COPD patients as well as to study it's effect in reducing exacerbation, improving exercise capacity and quality of life in stable COPD patients.
Study design: Randomized double blinded placebo controlled trial in Kwong Wah Hospital
Methodology: Patients are recruited in Kwong Wah Hospital if they fulfill the spirometric criteria of COPD. Eligible subjects will be randomized into the treatment (NAC 600mg tablet twice daily) and placebo group after completion of run in period. NAC and placebo will be prescribed accordingly in addition to their usual therapy. Both patients and investigators are blinded about the group allocation. Baseline assessment will be done and patients will be followed up at 16th weeks and 52th week of the study.
During each follow-up visit, hyperinflation parameters like inspiratory capacity (IC) will be measured by plethysmography. Airway resistance will be measured by both plethysmography and impulse oscillometry machine. Exercise capacity (6 min walking distance) and quality of life are also recorded during each follow up.
The difference of the above parameters between the 2 groups (drug and placebo group) will be analyszed by the Repeated measures ANOVA test
2,591 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 133 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Kwong Wah Hospital is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo (600mg twice daily)
Drug: Placebo
N-acetylcysteine (600mg twice daily)
Drug: N-acetycysteine (600mg twice daily)
N-acetycysteine (600mg twice daily) for one year
Placebo (600mg twice daily)
Airtrapping in COPD patients
The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)
Time frame: At baseline (time 0 week)
Airtrapping in COPD patients
The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)
Time frame: At 16th week
Airtrapping in COPD patients
The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)
Time frame: At 52th Week
Airway resistance in COPD patients
Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.
Time frame: At baseline ( time 0)
Airway resistance in COPD patients
Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.
Time frame: At 16th week
Airway resistance in COPD patients
Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.
Time frame: At 52th week
Exercise capacity
Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist
Time frame: At baseline ( time 0)
Exercise capacity
Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist
Time frame: At 16th week
Exercise capacity
Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist
Time frame: At 52th week
Quality of life
Quality of life is assessed by using the St Qeorge Respiratory Questionnaire (SQRQ)and it will be performed by a trained physiotherapist
Time frame: At baseline (time 0)
Quality of life
Quality of life is assessed by using the St Qeorge Respiratory Questionnaire (SQRQ)and it will be performed by a trained physiotherapist
Time frame: At 16th week
Quality of life
Quality of life is assessed by using the St Qeorge Respiratory Questionnaire (SQRQ)and it will be performed by a trained physiotherapist
Time frame: At 52th week
COPD exacerbation rate
The number of COPD exacerbation (exacerbation was defined as 2 out of 3 of the following criteria; 1.increase in shortness of breath, 2. increase in sputum purulence or 3. increase in sputum volume) will be assessed and documented
Time frame: At 52th week
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Kwong Wah Hospital