COPDNCT01553812
The Assessment of Airway Resistance and Airtrapping in Elderly COPD Patients by Forced Oscillation Technique (FOT)
An observational study of COPD, run by Kwong Wah Hospital.
Trial summary
The study hypothesize that parameters of new function machine---'forced oscillation technique' (FOT) can correlate well with the conventional lung function data for measurement of airway resistance and airtrapping in elderly COPD patients. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- COPD
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2011
- Phase
- Observational
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients from both 'in-patient' and 'outpatient clinic' in Kwong Wah Hospital, Hong Kong, China
Who may be able to join
- COPD patients with previous lung function tests confirming irreversible obstructive pattern
Who cannot join
- Lung function test failed to show any obstructive pattern
- Paitents with co-existing pulmonary diseases including asthma, interstitial lung diseases, lung malignancy etc.
- Patients with active infectious diseases like tuberculosis
About this study
The study hypothesize that parameters of new function machine---'forced oscillation technique' (FOT) can correlate well with the conventional lung function data for measurement of airway resistance and airtrapping in elderly COPD patients.
Read the detailed description
INTRODUCTION:
Forced oscillation technique (FOT) may be a good supplementary tool to assess lung function in elderly since it is a simple and fast tool requiring minimal patients' cooperation.
AIMS:
To investigate the accuracy of forced oscillation test FOT in assessment of airway resistance and airtrapping in elderly COPD patients by comparing FOT parameters to various conventional lung function parameters including FEV1, FEF 25-75, RV/TLC ratio, IC etc. The best FOT parameter for airway resistance and airtrapping is also determined.
STUDY DESIGN:
A cross-sectional study conducted in Kwong Wah Hospital, Hong Kong, SAR
METHODS:
COPD patients were recruited from 1st Jan, 2010 to 31st Dec 2011. Both of the lung function tests (forced oscillation technique (FOT) and conventional lung function test) were performed. Parameters of FOT (FRes FDep, RAvr, XAvr, were compared with conventional lung function test for assessment of both airway resistance and airtrapping in COPD subjects. Adjusted FOT parameters (FResRatio and FDep) were also compared with %FEV1 and different GOLD stages.
Statistics:
Comparison between FOT parameters and spirometric parameters was done by correlation test and expressed as Spearman coefficient. ANOVA test is used to compare FOT parameters among different groups of GOLD stages (stage 1 to 4) and groups with various degree of airtrapping (stage 1 to 3). Post hoc analysis was estimated by Bonferroni test.
- Conditions
- COPD
- Keywords
- forced oscillation technique, COPD, elderly, airway resistance, airtrapping
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 158 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553812
- Sponsor's protocol ID
- KW/EX-12-030 (48-15)
- Status last verified
- Mar 2012
- First submitted
- 12 Mar 2012
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tse HN, Tseng CZ, Wong KY, Yee KS, Ng LY. Accuracy of forced oscillation technique to assess lung function in geriatric COPD population. Int J Chron Obstruct Pulmon Dis. 2016 May 26;11:1105-18. doi: 10.2147/COPD.S102222. eCollection 2016.
PubMed 27307726
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Airway Resistance and Airtrapping in Elderly COPD Patients by Forced Oscillation Technique (FOT)
- ClinicalTrials.gov ID
- NCT01553812
- Acronym / sponsor ID
- KW/EX-12-030 (48-15)
- Conditions
- COPD
- Keywords
- forced oscillation technique, COPD, elderly, airway resistance, airtrapping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Kwong Wah HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Mar 2012 (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.
The study hypothesize that parameters of new function machine---'forced oscillation technique' (FOT) can correlate well with the conventional lung function data for measurement of airway resistance and airtrapping in elderly COPD patients.
Detailed description
INTRODUCTION:
Forced oscillation technique (FOT) may be a good supplementary tool to assess lung function in elderly since it is a simple and fast tool requiring minimal patients' cooperation.
AIMS:
To investigate the accuracy of forced oscillation test FOT in assessment of airway resistance and airtrapping in elderly COPD patients by comparing FOT parameters to various conventional lung function parameters including FEV1, FEF 25-75, RV/TLC ratio, IC etc. The best FOT parameter for airway resistance and airtrapping is also determined.
STUDY DESIGN:
A cross-sectional study conducted in Kwong Wah Hospital, Hong Kong, SAR
METHODS:
COPD patients were recruited from 1st Jan, 2010 to 31st Dec 2011. Both of the lung function tests (forced oscillation technique (FOT) and conventional lung function test) were performed. Parameters of FOT (FRes FDep, RAvr, XAvr, were compared with conventional lung function test for assessment of both airway resistance and airtrapping in COPD subjects. Adjusted FOT parameters (FResRatio and FDep) were also compared with %FEV1 and different GOLD stages.
Statistics:
Comparison between FOT parameters and spirometric parameters was done by correlation test and expressed as Spearman coefficient. ANOVA test is used to compare FOT parameters among different groups of GOLD stages (stage 1 to 4) and groups with various degree of airtrapping (stage 1 to 3). Post hoc analysis was estimated by Bonferroni test.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients from both 'in-patient' and 'outpatient clinic' in Kwong Wah Hospital, Hong Kong, China
Key inclusion criteria (1 listed)
- COPD patients with previous lung function tests confirming irreversible obstructive pattern
Key exclusion criteria (3 listed)
- Lung function test failed to show any obstructive pattern
- Paitents with co-existing pulmonary diseases including asthma, interstitial lung diseases, lung malignancy etc.
- Patients with active infectious diseases like tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Mar 2012.
- Derived from this study: PubMed 27307726Tse HN, Tseng CZ, Wong KY, Yee KS, Ng LY. Accuracy of forced oscillation technique to assess lung function in geriatric COPD population. Int J Chron Obstruct Pulmon Dis. 2016 May 26;11:1105-18. doi: 10.2147/COPD.S102222. eCollection 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Kwong Wah Hospital.
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 1 inclusion and 3 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 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01553812, which also lists 1 linked publication.
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 14 Mar 2012.