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Status unknownNCT03424083Updated Feb 9, 2018

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

An observational study in Respiratory Disease, sponsored by Centre Hospitalier Universitaire Saint Pierre. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-09.

Sponsored by Centre Hospitalier Universitaire Saint Pierre · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Respiration Disorders with a site in Belgium — none open to participants now, 2 under way, none of them phase 3. Respiration Disorders · Belgium.

Started
2017
with 3 others
Observational
7 of 21
none open now
Registered
13th of 21
by date
Lead sponsor
1 of 21
Centre Hospitalier Universitaire Saint Pierre

Among the 21 studies in Respiration Disorders with a site in Belgium, this one is one of 4 that started in 2017, is one of 7 observational ones, and was the 13th registered.

Respiration Disorders

359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.

Browse Respiration Disorders studies →

Open to participants now

None of the 21 studies in Respiration Disorders with a site in Belgium is open now. The open studies under Respiration Disorders, anywhere →

Who these studies take

Of the 45 Respiration Disorders studies recruiting now, 27 (60%) set no upper age limit and 13 (29%) stop at 75 or younger; 15 take children under 18; 21 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 21 studies in Respiration Disorders with a site in Belgium as a file.
02

Study summary

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.

03

Conditions studied

  • Respiratory Disease

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 1 cohort

    adult 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

06

What researchers measure

Primary outcomes

  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

    Time frame: at study completion

Secondary outcomes

  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

    Time frame: 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

    Time frame: at study completion

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2017 (actual). Primary completion is estimated for Jul 2018, 15 months after the start.

Of 60 non-industry observational studies under Respiration Disorders, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 15 months is below that.

Counting every sponsor, half of 75 studies reached it within 26 months; a quarter within 10 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2018
First posted
Feb 6, 2018
StartActual
Apr 25, 2017
Primary completionEst.
Jul 25, 2018
CompletionEst.
Sep 25, 2018
Last update
Feb 9, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03424083
Lead sponsor
Centre Hospitalier Universitaire Saint Pierre
Responsible party
Sponsor
First posted
Feb 6, 2018
Start date
Apr 25, 2017
Primary completion
Jul 25, 2018 (estimated)
Completion
Sep 25, 2018 (estimated)
Last update
Feb 9, 2018

Study contacts

Maria Gabrovska, M.D.
Contact
maria_gabrovska@stpierre.bru-be
00325353368
Vincent Ninane, M.D.,PhD
Contact
vincent_ninane@stpierre-bru.be
00325354276
Vincent Ninane, M.D., PhD
principal investigator · CHU St Pierre

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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