Respiratory SymptomsBPFSNCT01297881
Belgian Pulmonary Function Study
An observational study of Respiratory Symptoms, run by Marc Decramer at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Symptoms
- How many people
- 1,000 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2011to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Caucasian outpatients with respiratory symptoms but without diagnosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Respiratory Symptoms
- Keywords
- Caucasian outpatients, undiagnosed respiratory symptoms, dyspnea, cough, sputum
- Medical subject headings
- Signs and Symptoms, Respiratory, Dyspnea, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: end of study
Secondary outcomes (4)
% 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)
Measured: end of study
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
Measured: end of study
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"
Measured: end of study
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
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marc Decramer
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Pulmonary Society
- Responsible party
- Sponsor-investigator, Marc Decramer, KU Leuven
- Investigators
- Marc MD Decramer, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297881
- Sponsor's protocol ID
- S52460
- Acronym
- BPFS
- Status last verified
- Mar 2013
- First submitted
- 16 Feb 2011
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Decramer M, Janssens W, Derom E, Joos G, Ninane V, Deman R, Van Renterghem D, Liistro G, Bogaerts K; Belgian Pulmonary Function Study Investigators. Contribution of four common pulmonary function tests to diagnosis of patients with respiratory symptoms: a prospective cohort study. Lancet Respir Med. 2013 Nov;1(9):705-13. doi: 10.1016/S2213-2600(13)70184-X. Epub 2013 Oct 4.
PubMed 24429274
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgian Pulmonary Function Study : the Belgian Thoracic Society
- ClinicalTrials.gov ID
- NCT01297881
- Acronym / sponsor ID
- BPFS / S52460
- Conditions
- Respiratory Symptoms
- Keywords
- Caucasian outpatients, undiagnosed respiratory symptoms, dyspnea, cough, sputum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Marc DecramerUniversity, hospital or other
- Collaborators
- Belgian Pulmonary Society
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Caucasian outpatients with respiratory symptoms but without diagnosis
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- Patients with diagnosed respiratory disease
- Younger than 18 and older than 75 years old
- Recent heart attack
- Pneumothorax
- hemoptoic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
% correct preferential diagnoses
Time frame: end of study
N differential diagnoses in the subgroup with correct preferential diagnosis
Time frame: end of study
subgroup analyses
Time frame: end of study
Sensitivity analysis
Time frame: end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Derived from this study: PubMed 24429274Decramer M, Janssens W, Derom E, Joos G, Ninane V, Deman R, Van Renterghem D, Liistro G, Bogaerts K; Belgian Pulmonary Function Study Investigators. Contribution of four common pulmonary function tests to diagnosis of patients with respiratory symptoms: a prospective cohort study. Lancet Respir Med. 2013 Nov;1(9):705-13. doi: 10.1016/S2213-2600(13)70184-X. Epub 2013 Oct 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc MD Decramer, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Symptoms, run by Marc Decramer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary function tests (spirometry, volumes, resistance and diffusing capacity in that order) on the preferential diagnosis. (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01297881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013.