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

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ClinicalTrials.gov Identifier: NCT01136239
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Tse Hoi Nam, Kwong Wah Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
COPD Drug: N-acetycysteine (600mg twice daily) Drug: Placebo Phase 4

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo (600mg twice daily)
 Drug: Placebo
Placebo (600mg twice daily)
Active Comparator: N-acetylcysteine
N-acetylcysteine (600mg twice daily)
 Drug: N-acetycysteine (600mg twice daily)
N-acetycysteine (600mg twice daily) for one year


Outcome Measures
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Primary Outcome Measures :
  1. Airtrapping in COPD patients [ Time Frame: At baseline (time 0 week) ]
    The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)

  2. Airtrapping in COPD patients [ Time Frame: At 16th week ]
    The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)

  3. Airtrapping in COPD patients [ Time Frame: At 52th Week ]
    The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)


Secondary Outcome Measures :
  1. Airway resistance in COPD patients [ Time Frame: At baseline ( time 0) ]
    Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.

  2. Airway resistance in COPD patients [ Time Frame: At 16th week ]
    Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.

  3. Airway resistance in COPD patients [ Time Frame: At 52th week ]
    Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.

  4. Exercise capacity [ Time Frame: At baseline ( time 0) ]
    Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist

  5. Exercise capacity [ Time Frame: At 16th week ]
    Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist

  6. Exercise capacity [ Time Frame: At 52th week ]
    Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist

  7. Quality of life [ Time Frame: 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

  8. Quality of life [ Time Frame: At 16th week ]
    Quality of life is assessed by using the St Qeorge Respiratory Questionnaire (SQRQ)and it will be performed by a trained physiotherapist

  9. Quality of life [ Time Frame: At 52th week ]
    Quality of life is assessed by using the St Qeorge Respiratory Questionnaire (SQRQ)and it will be performed by a trained physiotherapist

  10. COPD exacerbation rate [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136239


Locations
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China
Medical Department
Hong Kong, China
Sponsors and Collaborators
Kwong Wah Hospital
Investigators
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Principal Investigator: Hoi Nam Tse, FHKAM, MBChB Kwong Wah Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tse Hoi Nam, Specialist in Respiratory medicine, Kwong Wah Hospital
ClinicalTrials.gov Identifier: NCT01136239    
Other Study ID Numbers: KW/EX/09-140
PR/CT 324/2009 ( Other Identifier: Department of Health, Hong Kong )
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015
Keywords provided by Tse Hoi Nam, Kwong Wah Hospital:
COPD
N-acetylcysteine
airtrapping
airway resistance
antioxidant
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases