Belgian Pulmonary Function Study

Respiratory Symptoms Clinical Trial

— BPFS  

Official title:

Belgian Pulmonary Function Study : the Belgian Thoracic Society

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297881
• Other study ID #: S52460
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: March 4, 2013
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Katholieke Universiteit Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Symptoms
• Signs and Symptoms, Respiratory

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven	Flanders

Sponsors (2)

Lead Sponsor	Collaborator
Marc Decramer	Belgian Pulmonary Society

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	% correct preferential diagnoses	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)	end of study	No
Secondary	N differential diagnoses in the subgroup with correct 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 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	end of study	No
Secondary	subgroup analyses	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"	end of study	No
Secondary	Sensitivity analysis	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	end of study	No