Belgian Pulmonary Function Study (BPFS)

This study has been completed.
Sponsor:
Collaborator:
Belgian Pulmonary Society
Information provided by (Responsible Party):
Marc Decramer, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01297881
First received: February 16, 2011
Last updated: March 4, 2013
Last verified: March 2013

February 16, 2011
March 4, 2013
June 2011
June 2012   (final data collection date for primary outcome measure)
pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the preferential diagnosis. [ Time Frame: end of study ] [ Designated as safety issue: No ]
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.
pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the preferential diagnosis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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).
Complete list of historical versions of study NCT01297881 on ClinicalTrials.gov Archive Site
  • % correct preferential diagnoses [ Time Frame: end of study ] [ Designated as safety issue: No ]
    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)
  • N differential diagnoses in the subgroup with correct preferential diagnosis [ Time Frame: end of study ] [ Designated as safety issue: No ]
    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
  • subgroup analyses [ Time Frame: end of study ] [ Designated as safety issue: No ]
    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"
  • Sensitivity analysis [ Time Frame: end of study ] [ Designated as safety issue: No ]
    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
pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the number of differential diagnoses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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).
Not Provided
Not Provided
 
Belgian Pulmonary Function Study
Belgian Pulmonary Function Study : the Belgian Thoracic Society

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Caucasian outpatients with respiratory symptoms but without diagnosis

Respiratory Symptoms
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
December 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01297881
S52460
No
Marc Decramer, Katholieke Universiteit Leuven
Marc Decramer
Belgian Pulmonary Society
Principal Investigator: Marc MD Decramer, PhD Universitaire Ziekenhuizen Leuven
Katholieke Universiteit Leuven
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP