COPD Clinical Trial
Official title:
The Effect of High Dose N-acetylcysteine on Airtrapping and Airway Resistance of Chronic Obstructive Pulmonary disease-a Double Blinded Randomized Placebo Controlled Trial
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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