NCT03424083

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

January 24, 2018

Last Update Submit

February 8, 2018

Conditions

Respiratory Disease

Outcome Measures

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

    at study completion

Secondary Outcomes (2)

  • number of cases in which additional tests were performed

    at study completion

  • changes in treatment after the four lung function tests

    at study completion

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU St Pierre

Brussels, 1000, Belgium

RECRUITING

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Vincent Ninane, M.D., PhD

    CHU St Pierre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Gabrovska, M.D.

CONTACT

00325353368maria_gabrovska@stpierre.bru-be

Vincent Ninane, M.D.,PhD

CONTACT

00325354276vincent_ninane@stpierre-bru.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 6, 2018

Study Start

April 25, 2017

Primary Completion

July 25, 2018

Study Completion

September 25, 2018

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

BE(1)