Belgian Pulmonary Function Study (BPFS)
| Tracking Information | |||||
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| First Received Date ICMJE | February 16, 2011 | ||||
| Last Updated Date | March 4, 2013 | ||||
| Start Date ICMJE | June 2011 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
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). |
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| Change History | Complete list of historical versions of study NCT01297881 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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). |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Belgian Pulmonary Function Study | ||||
| Official Title ICMJE | Belgian Pulmonary Function Study : the Belgian Thoracic Society | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Caucasian outpatients with respiratory symptoms but without diagnosis |
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| Condition ICMJE | Respiratory Symptoms | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 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. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1000 | ||||
| Completion Date | December 2012 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01297881 | ||||
| Other Study ID Numbers ICMJE | S52460 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Marc Decramer, Katholieke Universiteit Leuven | ||||
| Study Sponsor ICMJE | Marc Decramer | ||||
| Collaborators ICMJE | Belgian Pulmonary Society | ||||
| Investigators ICMJE |
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| Information Provided By | Katholieke Universiteit Leuven | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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