NCT01136239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

June 1, 2010

Last Update Submit

April 8, 2015

Conditions

COPD

Keywords

COPDN-acetylcysteineairtrappingairway resistanceantioxidant

Outcome Measures

Primary Outcomes (3)

  • 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)

  • Airtrapping in COPD patients

    The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)

    At 16th week

  • Airtrapping in COPD patients

    The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)

    At 52th Week

Secondary Outcomes (10)

  • Airway resistance in COPD patients

    At baseline ( time 0)

  • Airway resistance in COPD patients

    At 16th week

  • Airway resistance in COPD patients

    At 52th week

  • Exercise capacity

    At baseline ( time 0)

  • Exercise capacity

    At 16th week

  • +5 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (600mg twice daily)

Drug: Placebo

N-acetylcysteine

ACTIVE COMPARATOR

N-acetylcysteine (600mg twice daily)

Drug: N-acetycysteine (600mg twice daily)

Interventions

N-acetycysteine (600mg twice daily)DRUG

N-acetycysteine (600mg twice daily) for one year

N-acetylcysteine
PlaceboDRUG

Placebo (600mg twice daily)

Placebo

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Department

Hong Kong, China

Location

Related Publications (2)

  • Tse HN, Raiteri L, Wong KY, Ng LY, Yee KS, Tseng CZS. Benefits of high-dose N-acetylcysteine to exacerbation-prone patients with COPD. Chest. 2014 Sep;146(3):611-623. doi: 10.1378/chest.13-2784.

    PMID: 24833327DERIVED

  • Tse HN, Raiteri L, Wong KY, Yee KS, Ng LY, Wai KY, Loo CK, Chan MH. High-dose N-acetylcysteine in stable COPD: the 1-year, double-blind, randomized, placebo-controlled HIACE study. Chest. 2013 Jul;144(1):106-118. doi: 10.1378/chest.12-2357.

    PMID: 23348146DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hoi Nam Tse, FHKAM, MBChB

    Kwong Wah Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Respiratory medicine

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 3, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

CN(1)