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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Kwong Wah Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kwong Wah Hospital
ClinicalTrials.gov Identifier:
NCT01136239
First received: June 1, 2010
Last updated: June 2, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
COPD
Drug: N-acetycysteine (600mg twice daily)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Kwong Wah Hospital:

Primary Outcome Measures:
  • Airtrapping in COPD patients [ Time Frame: At baseline (time 0 week) ] [ Designated as safety issue: No ]
    The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)

  • Airtrapping in COPD patients [ Time Frame: At 16th week ] [ Designated as safety issue: No ]
    The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)

  • Airtrapping in COPD patients [ Time Frame: At 52th Week ] [ Designated as safety issue: No ]
    The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)


Secondary Outcome Measures:
  • Airway resistance in COPD patients [ Time Frame: At baseline ( time 0) ] [ Designated as safety issue: No ]
    Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.

  • Airway resistance in COPD patients [ Time Frame: At 16th week ] [ Designated as safety issue: No ]
    Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.

  • Airway resistance in COPD patients [ Time Frame: At 52th week ] [ Designated as safety issue: No ]
    Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.

  • Exercise capacity [ Time Frame: At baseline ( time 0) ] [ Designated as safety issue: No ]
    Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist

  • Exercise capacity [ Time Frame: At 16th week ] [ Designated as safety issue: No ]
    Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist

  • Exercise capacity [ Time Frame: At 52th week ] [ Designated as safety issue: No ]
    Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist

  • Quality of life [ Time Frame: At baseline (time 0) ] [ Designated as safety issue: No ]
    Quality of life is assessed by using the St Qeorge Respiratory Questionnaire (SQRQ)and it will be performed by a trained physiotherapist

  • Quality of life [ Time Frame: At 16th week ] [ Designated as safety issue: No ]
    Quality of life is assessed by using the St Qeorge Respiratory Questionnaire (SQRQ)and it will be performed by a trained physiotherapist

  • Quality of life [ Time Frame: At 52th week ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 52th week ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: February 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136239

Contacts
Contact: Hoi Nam Tse, MBChB 852-92116036 drhoinam@gmail.com

Locations
China
Medical Department Recruiting
Hong Kong, China
Contact: Hoi Nam Tse, FHKAM, MBChB    852-92116036    drhoinam@gmail.com   
Sponsors and Collaborators
Kwong Wah Hospital
Investigators
Principal Investigator: Hoi Nam Tse, FHKAM, MBChB Kwong Wah Hospital
  More Information

No publications provided by Kwong Wah Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Tse Hoi Nam, Kwong Wah Hospital
ClinicalTrials.gov Identifier: NCT01136239     History of Changes
Other Study ID Numbers: KW/EX/09-140, PR/CT 324/2009
Study First Received: June 1, 2010
Last Updated: June 2, 2010
Health Authority: Hong Kong: Department of Health
United States: Food and Drug Administration

Keywords provided by Kwong Wah Hospital:
COPD
N-acetylcysteine
airtrapping
airway resistance
antioxidant

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on July 22, 2014