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Respiratory DiseaseNCT03424083

Contribution of Four Pulmonary Function Tests to Diagnosis in the Primary Care.

An observational study of Respiratory Disease, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Contribution of four pulmonary function tests to diagnosis in patients with respiratory symptoms in the primary care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Disease
How many people
100 participants
Where
1 siteBelgium
Study dates
25 Apr 2017to 25 Sep 2018
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: * all patients, send by a general practitioner to our lung function lab * adults patients (older than 18 years and younger than 80 years), both sexes * not followed by a pulmonologist * no previous diagnosis and established treatment

Who may be able to join

  • all subjects: 18 or older than 18 years old and younger than 80 years old
  • send by a general practitioner for a lung function test

Who cannot join

  • subjects, younger than 18 years old
  • not able to perform the lung function tests
  • incomplete lung function tests
  • disease already diagnosed
  • already follow up by a pulmonologist
  • preoperative test

Trial locations and contacts

1 site in 1 country.

Maria Gabrovska, M.D. contact

00325353368

maria_gabrovska@stpierre.bru-be

Vincent Ninane, M.D.,PhD contact

00325354276

vincent_ninane@stpierre-bru.be

Belgium1 site, 1 recruiting
  • CHU St Pierre

    Brussels, 1000

    Maria Gabrovska, M.D., 00325353368, maria_gabrovska@stpierre-bru.be

    Vincent Ninane, M.D., PhD, 00325354276, vincent_ninane@stpierre-bru.be

    Recruiting

Other trials in Belgium

About this study

Official title: Contribution of Four Pulmonary Function Tests to Diagnosis in Patients With Respiratory Symptoms in the Primary Care.

Contribution of four pulmonary function tests to diagnosis in patients with respiratory symptoms in the primary care.

Read the detailed description

Background Pulmonary function tests are routinely used for the diagnosis of respiratory conditions. Few studies have been conducted, assessing the use of the pulmonary function tests and their contribution to the diagnosis in patients with respiratory symptoms. A recent study in 33 chest services from Belgian hospitals have shown that each of the four common pulmonary function tests (spirometry, lung volume, airway resistance and diffusing capacity) contributes significantly to the final diagnosis made by pulmonologists in new patients with respiratory symptoms.

Primary care physicians however treat the majority of patients with respiratory symptoms and often use a symptom-based approach to make a diagnosis (2). Diagnostic spirometry remains largely underused in primary care and is probably mainly performed in the care of patients with asthma and chronic obstructive pulmonary disease (COPD). Drawbacks of home spirometry also include poorly performed tests and incorrect interpretation of the results (3). In addition, primary care physicians have no access to the three other common pulmonary function tests that contribute independently to the diagnosis of respiratory diseases (1).

Since 2015, our chest service localized in the center of Brussels offers a direct and open access to the lung function laboratory to all the patients referred by their general practitioners. The four common tests are performed in their patients with respiratory symptoms but no clear diagnosis and the patients are not evaluated by the chest physicians. A protocol is however performed with potential advice for additional diagnostic tests (provocation tests, exhaled NO measurement, ergospirometry, imaging,…).

In the present study, we will assess the contribution of the four common pulmonary function tests to diagnosis in patients with respiratory symptoms in the primary care.

Methods Prospective single center cohort study. Adult patients, aged more than 18 years, presenting to the general practitioner with respiratory symptoms but without a clear diagnosis and referred by them for pulmonary function tests will be enrolled in the study. Patients will be excluded if they had diagnosed respiratory disease at our institution and if they are not able to perform pulmonary function testing.

The patients will not be seen or examined by a pulmonologist of the chest service. They will return to the referring family physician for further treatment.

Before lung function testing, the patients will be asked to fill in a questionnaire, including short questions about their medical history and respiratory medications, previous referrals to a pulmonologist, symptoms and comorbidities.

All patients, regardless of the suspected respiratory condition, will also be asked to complete the COPD assessment test (CAT test) to better quantify their symptoms.

The tests (spirometry, plethysmography, airway resistance measurement, diffusion capacity measurement) will then be performed by a qualified lung function lab technician. Interpretation of the results will be made by a pulmonologist. The protocol will be given to the patient or sent to the referring family physician and may also include proposals for additional diagnostic tests.

In second time, one month later, the general practitioner will be contacted by one of the investigators to receive more information about the final diagnosis based on all the investigations done and treatment.

The collected data will be processed in a database and analyzed anonymously. The primary outcome will be the increase in the proportion of diagnosis afforded by the four tests in comparison with spirometry alone. Secondary outcomes will be the proportion of patients without clear diagnosis, time to lung function tests and time to diagnosis.

Statistical analysis The present study is mainly descriptive and no hypothesis can be made on the contribution of additional lung function tests to the final diagnosis in a population of patients from general practitioners. The present study will include 100 patients with respiratory symptoms but no clear diagnosis.

Medical subject headings
Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03424083
Study groupRoleWhat they receive
1 cohortadult patients of both sexes (>18 and <80 years) with no previous diagnosis or follow up by a pulmonologist, send by a general practitioner to the lung function lab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of cases in which the four lung function tests are contributing to the final diagnosis

    number of cases in which the four lung function tests are contributing to the final established diagnosis compared to spirometry alone

    Measured: at study completion

Secondary outcomes (2)
  1. number of cases in which additional tests were performed

    number of cases in which additional tests were needed to establish the correct final diagnosis, after the performance of the four lung function tests

    Measured: at study completion

  2. changes in treatment after the four lung function tests

    changes in treatment, prescribed by the primary physician, after the performance of the four lung function tests

    Measured: at study completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2018
  2. Study start25 Apr 2017
  3. Primary completion25 Jul 2018 (estimated)
  4. Study completion25 Sep 2018 (estimated)

Resources

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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03424083
Sponsor's protocol ID
B076201731685
Status last verified
Feb 2018
First submitted
24 Jan 2018
Last updated
9 Feb 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Disease, run by Centre Hospitalier Universitaire Saint Pierre 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Feb 2018. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maria Gabrovska, M.D. (00325353368, maria_gabrovska@stpierre.bru-be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of cases in which the four lung function tests are contributing to the final diagnosis (time frame: at study completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 9 Feb 2018.

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