NCT00499304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

June 6, 2008

Status Verified

June 1, 2008

Enrollment Period

1.4 years

First QC Date

July 10, 2007

Last Update Submit

June 5, 2008

Conditions

COPD

Keywords

Forced oscillation Technique (FOT)Expiratory flow limitation (EFL)Breathing artifactsCOPD

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stable GOLD 2-4 COPD patients

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center Alkmaar

Alkmaar, 1815JD, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dewi Tjiong, drs

    Medical Center Alkmaar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 11, 2007

Study Start

November 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

June 6, 2008

Record last verified: 2008-06

Locations

NL(1)