COPD
Conditions
Keywords
COPD, N-acetylcysteine, airtrapping, airway resistance, antioxidant
Brief summary
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.
Detailed description
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
Interventions
DRUGN-acetycysteine (600mg twice daily)
N-acetycysteine (600mg twice daily) for one year
DRUGPlacebo
Placebo (600mg twice daily)
Sponsors
Kwong Wah Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Spirometry diagnosed COPD with FEV1/FVC ratio less than 70% and FEV1 less than 80% predicted * clinically stable and exacerbation free in the past 4 weeks * history of at least one COPD exacerbation in the past one year
Exclusion criteria
* patients allergic or intolerant to NAC * Recent use of NAC in the past one month * history of asthma, non COPD respiratory disorders like bronchiectasis, pneumoconiosis or any active pulmonary infection * patients on long term steroid * patients on long term oxygen therapy or non invasive ventilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airtrapping in COPD patients | At baseline (time 0 week) | The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Airway resistance in COPD patients | At baseline ( time 0) | Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry. |
| Exercise capacity | At baseline ( time 0) | Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist |
| Quality of life | At baseline (time 0) | Quality of life is assessed by using the St Qeorge Respiratory Questionnaire (SQRQ)and it will be performed by a trained physiotherapist |
| COPD exacerbation rate | At 52th week | 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 |
Countries
China
Outcome results
None listed