Trial record 1 of 1 for:    chronic obstructive pulmonary disease | NCT01136239
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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

June 1, 2010
June 2, 2010
February 2010
September 2011   (final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT01136239 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
The Effect of High Dose N-acetylcysteine on Airtrapping and Airway Resistance in Chronic Obstructive Pulmonary Disease (COPD) Patients
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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
COPD
  • Drug: N-acetycysteine (600mg twice daily)
    N-acetycysteine (600mg twice daily) for one year
  • Drug: Placebo
    Placebo (600mg twice daily)
  • Placebo Comparator: Placebo
    Placebo (600mg twice daily)
    Intervention: Drug: Placebo
  • Active Comparator: N-acetylcysteine
    N-acetylcysteine (600mg twice daily)
    Intervention: Drug: N-acetycysteine (600mg twice daily)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
40 Years to 85 Years
No
Contact: Hoi Nam Tse, MBChB 852-92116036 drhoinam@gmail.com
China
 
NCT01136239
KW/EX/09-140, PR/CT 324/2009
Yes
Dr. Tse Hoi Nam, Kwong Wah Hospital
Kwong Wah Hospital
Not Provided
Principal Investigator: Hoi Nam Tse, FHKAM, MBChB Kwong Wah Hospital
Kwong Wah Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP