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Completed

NCT Number: NCT01297881

Belgian Pulmonary Function Study

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.

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Key information

Conditions

Respiratory Symptoms Cough Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Leuven

Leuven, Flanders, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: end of study

    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.

Secondary outcomes

  1. % correct preferential diagnoses

    Time frame: end of study

    To determine the effect of stepwise addition of various pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on preferential diagnoses and their reflection of the gold standard (final diagnosis), the number and percentage of correct preferential diagnoses will be analysed after every pulmonary function test and compared by a generalized estimating equation model (GEE)

  2. N differential diagnoses in the subgroup with correct preferential diagnosis

    Time frame: end of study

    To determine the effect of stepwise addition of various pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the number of differential diagnoses and their reflection of the gold standard (final diagnosis), the number of differential diagnoses in patients with correct preferential diagnosis will be analysed after each pulmonary function test and compared with Poisson GEE

  3. subgroup analyses

    Time frame: end of study

    The primary endpoint (1/n differntial diagnoses) and 2 secondary endpoints (% correct preferential diagnoses, n differential diagnoses within correct preferential diagnosis) will be analysed in subgroups with final gold standard diagnosis of COPD, asthma, interstitial lung disease and " no pulmonary abnormality"

  4. Sensitivity analysis

    Time frame: end of study

    Primary endpoint (1/n differntial diagnoses) and 2 secondary endpoints (% correct preferential diagnoses, n differential diagnoses within correct preferential diagnosis) and subgroup analyses (asthma, COPD, interstitial lung disease and no primary pulmonary abnormality) will be evaluated not only considering final diagnosis as standard but als correct side diagnosis

Sponsors and collaborators

Lead sponsor

Marc Decramer

Other

Collaborators

  • Belgian Pulmonary Society

Registry information

Official study title

Belgian Pulmonary Function Study : the Belgian Thoracic Society

Acronym: BPFS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2011
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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