COPDPhase 4NCT01136239
The Effect of High Dose N-acetylcysteine on Airtrapping and Airway Resistance in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 4 study testing N-acetycysteine (600mg twice daily) in people with COPD, run by Kwong Wah Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- N-acetycysteine (600mg twice daily)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteChina
- Study dates
- Feb 2010to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- COPD
- Being tested
- N-acetycysteine (600mg twice daily), Placebo
- Keywords
- COPD, N-acetylcysteine, airtrapping, airway resistance, antioxidant
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetycysteine (600mg twice daily)Drug
N-acetycysteine (600mg twice daily) for one year
PlaceboDrug
Placebo (600mg twice daily)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (600mg twice daily) Receives: Drug: Placebo |
| N-acetylcysteine | Active comparator | N-acetylcysteine (600mg twice daily) Receives: Drug: N-acetycysteine (600mg twice daily) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airtrapping in COPD patients
The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)
Measured: 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)
Measured: At 16th week
Airtrapping in COPD patients
The airtrapping of COPD patients is measured by inspiratory capacity (IC), using plethsmography (MedGraphics Elite series)
Measured: At 52th Week
Secondary outcomes (10)
Airway resistance in COPD patients
Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.
Measured: At baseline ( time 0)
Airway resistance in COPD patients
Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.
Measured: At 16th week
Airway resistance in COPD patients
Airway resistance is measured by plethsmography (Medgraphics Elite series) and impulse oscillometry.
Measured: At 52th week
Exercise capacity
Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist
Measured: At baseline ( time 0)
Exercise capacity
Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist
Measured: At 16th week
Exercise capacity
Exercise capacity is measured by 6-min-walking distance (6MWD)and it is performed by a trained physiotherapist
Measured: At 52th week
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
Measured: At baseline (time 0)
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
Measured: At 16th week
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
Measured: At 52th week
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
Measured: At 52th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwong Wah Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tse Hoi Nam, Kwong Wah Hospital
- Investigators
- Hoi Nam Tse, FHKAM, MBChB, Principal investigator, Kwong Wah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136239
- Sponsor's protocol ID
- KW/EX/09-140
- Other IDs
- PR/CT 324/2009
- Status last verified
- Apr 2015
- First submitted
- 1 Jun 2010
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24833327Tse 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.
PubMed 23348146
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01136239
- Acronym / sponsor ID
- KW/EX/09-140
- Conditions
- COPD
- Keywords
- COPD, N-acetylcysteine, airtrapping, airway resistance, antioxidant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Kwong Wah HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (600mg twice daily) |
| N-acetylcysteine | Active comparator | Drug: N-acetycysteine (600mg twice daily)N-acetylcysteine (600mg twice daily) |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetycysteine (600mg twice daily)N-acetycysteine (600mg twice daily) for one year | Drug | N-acetylcysteine |
| PlaceboPlacebo (600mg twice daily) | Drug | Placebo |
Primary outcome
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)
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)
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)
10 secondary outcomes
Airway resistance in COPD patients
Time frame: At baseline ( time 0)
Airway resistance in COPD patients
Time frame: At 16th week
Airway resistance in COPD patients
Time frame: At 52th week
Exercise capacity
Time frame: At baseline ( time 0)
Exercise capacity
Time frame: At 16th week
Exercise capacity
Time frame: At 52th week
Quality of life
Time frame: At baseline (time 0)
Quality of life
Time frame: At 16th week
Quality of life
Time frame: At 52th week
COPD exacerbation rate
Time frame: At 52th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Derived from this study: PubMed 24833327Tse 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.
- Derived from this study: PubMed 23348146Tse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hoi Nam Tse, FHKAM, MBChB principal investigator
Kwong Wah Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-acetycysteine (600mg twice daily) in people with COPD, run by Kwong Wah Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airtrapping in COPD patients (time frame: At baseline (time 0 week)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01136239, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.