NCT03197701

Brief Summary

The general objective of this project is to determine the best method to measure maximal inspiratory flow rates, to study their reproducibility and create reference equations in healthy subjects.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

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

September 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

July 18, 2017

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

June 22, 2017

Last Update Submit

July 13, 2017

Conditions

Lung Function

Keywords

Lung functionInspiratory flow rates

Outcome Measures

Primary Outcomes (2)

  • Normal values for maximal inspiratory flow rates

    Peak inspiratory flow rate (PIF)

    3 years

  • Normal values for maximal inspiratory flow rates

    Maximal flow rate when 50% of inspiratory vital capacity has been inhaled (FIF50)

    3 years

Secondary Outcomes (1)

  • Reproducibility of maximal inspiratory flow rates

    3 years

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal healthy subjects

You may qualify if:

  • healthy hospital workers or visitors

You may not qualify if:

  • current smokers or ex-smokers with a history of \> 80 PY
  • Presence or history of serious illness or thorax deformity (questionnaire)
  • recent respiratory tract infection (1 week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

Study Officials

  • Shane Hanon, MD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shane Hanon, MD

CONTACT

+3224776841shane.hanon@uzbrussel.be

Daniel Schuermans, RN

CONTACT

daniel.schuermans@uzbrussel.be

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2017

First Posted

June 23, 2017

Study Start

September 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2019

Last Updated

July 18, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)