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
  Purpose

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.


Condition
Respiratory Symptoms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Belgian Pulmonary Function Study : the Belgian Thoracic Society

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • % 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


Enrollment: 1000
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Caucasian outpatients with respiratory symptoms but without diagnosis

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297881

Locations
Belgium
University Hospital Leuven
Leuven, Flanders, Belgium
Sponsors and Collaborators
Marc Decramer
Belgian Pulmonary Society
Investigators
Principal Investigator: Marc MD Decramer, PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Marc Decramer, MD PhD, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01297881     History of Changes
Other Study ID Numbers: S52460
Study First Received: February 16, 2011
Last Updated: March 4, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Katholieke Universiteit Leuven:
Caucasian outpatients
undiagnosed respiratory symptoms
dyspnea
cough
sputum

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014