COPDNCT00499304
Forced Oscillation Technique (FOT) and Expiratory Flow Limitation (EFL)
An observational study of COPD, run by Medical Center Alkmaar at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2006to Apr 2008
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stable GOLD 2-4 COPD patients
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosing Expiratory Flow Limitation in COPD Patients With the Forced Oscillation Technique Using Linear Regression in the Time Frequency Domain
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.
Read the 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.
- Conditions
- COPD
- Keywords
- Forced oscillation Technique (FOT), Expiratory flow limitation (EFL), Breathing artifacts, COPD
- 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 posted11 Jul 2007 (estimated)
- Study startNov 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Investigators
- Dewi Tjiong, drs, Principal investigator, Medical Center Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499304
- Sponsor's protocol ID
- NL13873.09406
- Status last verified
- Jun 2008
- First submitted
- 10 Jul 2007
- Last updated
- 6 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing Expiratory Flow Limitation in COPD Patients With the Forced Oscillation Technique Using Linear Regression in the Time Frequency Domain
- ClinicalTrials.gov ID
- NCT00499304
- Acronym / sponsor ID
- NL13873.09406
- Conditions
- COPD
- Keywords
- Forced oscillation Technique (FOT), Expiratory flow limitation (EFL), Breathing artifacts, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 11 Jul 2007 (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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stable GOLD 2-4 COPD patients
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- History of exacerbation of COPD in the preceding month
- Upper airway obstruction
- Allergic Asthma
- OSAS (obstructive sleep apnea syndrome)
- Extreme obesity (BMI>35)
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 6 Jun 2008.
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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.
Dewi Tjiong, drs principal investigator
Medical Center Alkmaar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Medical Center Alkmaar at 1 site in Netherlands.
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 6 inclusion and 6 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 6 Jun 2008. 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 Netherlands. 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. 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?
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 6 Jun 2008.