NCT03820427

Brief Summary

Current guideline-based criteria defining bronchial asthma do not always meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used functional diagnostic approaches for the detection and therapeutic monitoring of patients with asthma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

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

Study Start

First participant enrolled

August 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

3.3 years

First QC Date

January 22, 2019

Last Update Submit

January 27, 2019

Conditions

Bronchial AsthmaPulmonary Healthy Controls

Outcome Measures

Primary Outcomes (2)

  • Global ventilation heterogeneity

    lung clearance index (LCI) derived from sulphur hexafluoride multiple breath washout

    30 minutes

  • Local ventilation heterogeneity

    Sacin, Scond (Phase III slopes) derived from sulphur hexafluoride multiple breath washout

    30 minutes

Study Arms (2)

bronchial asthma

Patients with known or suspected asthma.

Diagnostic Test: impulse oscillometryDiagnostic Test: multiple breath washout testDiagnostic Test: body plethysmography

pulmonary healthy controls

Patients without known or suspected pulmonary disease

Diagnostic Test: impulse oscillometryDiagnostic Test: multiple breath washout testDiagnostic Test: body plethysmography

Interventions

impulse oscillometryDIAGNOSTIC_TEST

impulse oscillometry

bronchial asthmapulmonary healthy controls
multiple breath washout testDIAGNOSTIC_TEST

multiple breath washout test

bronchial asthmapulmonary healthy controls
body plethysmographyDIAGNOSTIC_TEST

body plethysmography

bronchial asthmapulmonary healthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with indication for routine lung function testing

You may qualify if:

  • known or suspected bronchial asthma
  • known or suspected obstructive ventilation disorder
  • pulmonary healthy controls

You may not qualify if:

  • pregnancy
  • inability to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Plethysmography, Whole Body

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PlethysmographyDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory System

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 29, 2019

Study Start

August 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 29, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share