NCT02563210

Brief Summary

In preschool aged children, the most suitable techniques to assess airway obstruction is debit interruption technic (Rint) and plethysmographic measure of specific airway resistance (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems to be better for discriminating airway obstruction. These two techniques will be compared in terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 15, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

October 19, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2017

Completed
Last Updated

April 11, 2019

Status Verified

June 1, 2017

Enrollment Period

1.6 years

First QC Date

September 15, 2015

Last Update Submit

April 10, 2019

Conditions

Airway Obstruction

Outcome Measures

Primary Outcomes (1)

  • airway resistance measure by interruption technique (Rint)

    Rint is performed using Spiroteq Dyn'R during a 100 ms occlusion and calculated using the linear back extrapolation method

    Day one

Secondary Outcomes (1)

  • measure of bronchodilator response

    Day one

Study Arms (1)

airway resistance measurement

EXPERIMENTAL

interruption and plethysmography techniques airway resistance measurement at each routine visit

Other: airway resistance measurement

Interventions

airway resistance measurementOTHER

assessment of airway resistance

airway resistance measurement

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child 3 to 6 years aged

You may not qualify if:

  • Height below 90 centimeters
  • Opposition to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Related Publications (1)

  • Mauger-Hamel P, Du Boisbaudry C, Leon K, Alavi Z, Giroux-Metges MA. Relationship between baseline and post-bronchodilator interrupter resistance and specific airway resistance in preschool children. Ann Allergy Asthma Immunol. 2020 Apr;124(4):366-372. doi: 10.1016/j.anai.2020.01.003. Epub 2020 Jan 13.

    PMID: 31945475DERIVED

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Marie-Agnès METGES, Pr

    University Hospital of Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2015

First Posted

September 30, 2015

Study Start

October 19, 2015

Primary Completion

May 29, 2017

Study Completion

May 29, 2017

Last Updated

April 11, 2019

Record last verified: 2017-06

Locations

FR(1)