The Assessment of Airway Resistance and Airtrapping in El... | NCT01553812

Studies
The Assessment of Airway Resistance and Airtrapping in Elderly COPD Patients by Forced Oscillation Technique (FOT)

NCT01553812

Sponsor

Kwong Wah Hospital

Status

Completed

Last Update Posted

Mar 14, 2012Estimated

Enrollment

158Actual

Phase

Not provided

Conditions

COPD

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 12, 2012

First Submission Date that Met QC Criteria

Mar 12, 2012

First Posted Date

Mar 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2012

Last Update Posted Date

Mar 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

158Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COPD patients with previous lung function tests confirming irreversible obstructive pattern

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

COPD patients from both 'in-patient' and 'outpatient clinic' in Kwong Wah Hospital, Hong Kong, China

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27307726	Derived	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.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease