Forced Oscillation Technique (FOT) and Expiratory Flow Limitation (EFL)

Completed

• Conditions: COPD

• Registration Number: NCT00499304
• Lead Sponsor: Medical Center Alkmaar

Brief Summary

The aim of this study is to distinguish COPD patients with expiratory flow limitation in body plethysmography (open loop) from the patients without expiratory flow limitation in body plethysmography (closed loop) with the obtained FOT parameters.

Detailed Description

In daily practice the expiratory flow limitation is measured by body plethysmography. An open loop in body plethysmography shows expiratory flow limitation in COPD patients. But body plethysmography requires that the patient quietly sits in a closed box and is not able to follow changes breath by breath. The goal of this study is to validate the Forced oscillation technique (FOT) for measuring expiratory flow limitation in COPD patients.30 COPD patients with an open loop in body plethysmography are compared to 30 COPD patients with a closed loop. The methods used in this study are the maximal overlap discrete short time Fourier transform (MODFT) combined with a total least squares analysis. It is hypothesized that the obtained FOT parameters are able to distinguish the patients with expiratory flow limitation in body plethysmography from the patients without expiratory flow limitation in body plethysmography.Secondary study questions are: 1) to what extend are the FOT parameters distorted by breathing artifacts and measurement noise. 2)What changes can be detected by FOT in expiratory flow limitation after administration of salbutamol.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-07-10
• Study First Submitted QC: 2007-07-10
• Study First Posted: 2007-07-11
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-05
• Last Update Posted: 2008-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Presenting to the outpatient clinic
• Age 50-80 years
• Diagnosed with COPD according to the standard criteria
• Gold Stage II to IV COPD
• Current or ex-smokers (at least 10 PY)
• Stable disease (No current exacerbation or exacerbation during the 4 weeks previous to the inclusion)

Exclusion Criteria

• History of exacerbation of COPD in the preceding month
• Upper airway obstruction
• Allergic Asthma
• OSAS (obstructive sleep apnea syndrome)
• Extreme obesity (BMI>35)
• Clinically manifest cardiac disease (for example clinically relevant congestive heart failure, unstable angina pectoris)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Medical Center Alkmaar; 🇳🇱 Alkmaar, Netherlands