The Effect of High Dose N-acetylcysteine on Airtrapping and Airway Resistance in Chronic Obstructive Pulmonary Disease (COPD) Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136239
• Other study ID #: KW/EX/09-140
• Secondary ID: PR/CT 324/2009
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2010
• Last updated: April 8, 2015
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: April 2015
• Source: Kwong Wah Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• N-acetycysteine (600mg twice daily)
N-acetycysteine (600mg twice daily) for one year
• Placebo
Placebo (600mg twice daily)

Locations

Country	Name	City	State
China	Medical Department	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Kwong Wah Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airtrapping in COPD patients	The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)	At baseline (time 0 week)	No
Primary	Airtrapping in COPD patients	The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)	At 16th week	No
Primary	Airtrapping in COPD patients	The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)	At 52th Week	No
Secondary	Airway resistance in COPD patients	Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.	At baseline ( time 0)	No
Secondary	Airway resistance in COPD patients	Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.	At 16th week	No
Secondary	Airway resistance in COPD patients	Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.	At 52th week	No
Secondary	Exercise capacity	Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist	At baseline ( time 0)	No
Secondary	Exercise capacity	Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist	At 16th week	No
Secondary	Exercise capacity	Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist	At 52th week	No
Secondary	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	At baseline (time 0)	No
Secondary	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	At 16th week	No
Secondary	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	At 52th week	No
Secondary	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	At 52th week	No