NCT01297881

Brief Summary

Pulmonary function tests including spirometry, lung volumes, measurements of resistance and diffusing capacity are essential in the diagnosis of several pulmonary diseases. These tests are an integral part of the diagnosis and treatment of lung diseases, but until now there is no clear evidence for the use of many of the pulmonary function tests because of a lack of adequate studies. The obscurity largely pertains to the conditions under which combinations of the various tests are indicated. Therefore the Belgian Thoracic Society, assembling all pulmonologists and the pneumology LOK/GLEM"s, will investigate this matter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

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

First Submitted

Initial submission to the registry

February 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

February 16, 2011

Last Update Submit

March 4, 2013

Conditions

Respiratory Symptoms

Keywords

Caucasian outpatientsundiagnosed respiratory symptomsdyspneacoughsputum

Outcome Measures

Primary Outcomes (1)

  • pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the preferential diagnosis.

    To determine the effect of stepwise addition of various pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the preferential diagnosis and its reflection of the gold standard (final diagnosis), a statistical score will be calculated based on 1/n differential diagnoses after every pulmonary function test. The score will contain corrections for a high number of differential diagnoses and a wrong preferential diagnosis and compared with Linear mixed model after logistic transformation.

    end of study

Secondary Outcomes (4)

  • % correct preferential diagnoses

    end of study

  • N differential diagnoses in the subgroup with correct preferential diagnosis

    end of study

  • subgroup analyses

    end of study

  • Sensitivity analysis

    end of study

Study Arms (1)

Caucasian outpatients with respiratory symptoms

all consecutive new Caucasian outpatients with respiratory symptoms like dyspnoea, cough, sputum but without diagnosis who are being examined for the first time.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Caucasian outpatients with respiratory symptoms but without diagnosis

You may qualify if:

  • Males and females
  • Age between 18 and 75 years old
  • New outpatients with respiratory symptoms as dyspnoea, cough, sputum, but without firm diagnosis
  • Results of the tests are available and acceptable
  • Standardized list of complaints
  • Capability of patient for doing pulmonary function tests
  • Seen by a Pneumologist
  • Written informed consent

You may not qualify if:

  • Patients with diagnosed respiratory disease
  • Younger than 18 and older than 75 years old
  • Recent heart attack
  • Pneumothorax
  • hemoptoic
  • Suspicion of Tuberculosis
  • Not capable to do pulmonary function tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Leuven

Leuven, Flanders, Belgium

Location

Related Publications (1)

  • Decramer M, Janssens W, Derom E, Joos G, Ninane V, Deman R, Van Renterghem D, Liistro G, Bogaerts K; Belgian Pulmonary Function Study Investigators. Contribution of four common pulmonary function tests to diagnosis of patients with respiratory symptoms: a prospective cohort study. Lancet Respir Med. 2013 Nov;1(9):705-13. doi: 10.1016/S2213-2600(13)70184-X. Epub 2013 Oct 4.

    PMID: 24429274DERIVED

MeSH Terms

Conditions

Signs and Symptoms, RespiratoryDyspneaCough

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Marc MD Decramer, PhD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 17, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

BE(1)