NCT04163146

Brief Summary

Long-term variability analysis of peak expiratory flow (PEF) and forced expiratory volume in 1 s (FEV1) has been successfully used in research to predict the exacerbation of the disease in adult individuals with asthma. However, there is a paucity of data regarding PEF and FEV1 variability in asthmatic children and adolescents. Such a task requires at least daily PEF and FEV1 measurements, recording in diaries, and periodic evaluation of the data. The process may be proven both complicated and time consuming, thus reducing patients' adherence. Recent advances in biosensor technology have permitted the development of reliable, low-cost, portable spirometers, able to connect with smartphones and monitor lung function parameters in real time and from a distance. The objectives of the present study is the assessment of PEF and FEV1 variability: a) in healthy children and adolescents, in order to define the normal daily fluctuation of PEF and FEV1 and the parameters that may influence it, and b) in children and adolescents with asthma, in order to explore the differences from healthy subjects and reveal any specific variability changes prior to exacerbation. Such data would improve our understanding regarding the disease and permit the development of integrated tools for assessing the level of asthma control and the risk of future exacerbations. The study will include 100 healthy children and adolescents aged 6 to 18 years for the assessment of normal PEF and FEV1 variability, and 100 children and adolescents of the same age with diagnosed asthma for the assessment of PEF and FEV1 variability in asthmatics. PEF and FEV1 measurements will be performed using an FDA-approved portable spirometer (MIR Spirobank Smart) capable to connect to smartphone. Each participant will receive his personal spirometer. Measurements will be performed twice a day between 07:00-09:00 and 19:00-21:00 hours and dispatched via email to a central database for a period of 3 months. PEF and FEV1 variability will be assessed by detrended fluctuation analysis, aiming to define the normal pattern (healthy controls) and to detect and quantify the deviations (asthmatics). The anticipated duration of the study is 24 months.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

November 9, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

2 years

First QC Date

November 9, 2019

Last Update Submit

April 27, 2021

Conditions

Asthma in ChildrenLung Function Decreased

Keywords

AsthmaLung function variabilityChildrenAdolescents

Outcome Measures

Primary Outcomes (2)

  • PEF variability

    Daily fluctuations in PEF values

    3 months

  • FEV1 variability

    Daily fluctuations in FEV1 values

    3 months

Study Arms (2)

Healthy children and adolescents

EXPERIMENTAL

Healthy children and adolescents aged 6 to 18 years (N=100) for the assessment of normal PEF and FEV1 variability.

Diagnostic Test: Measurements of PEF and FEV1

Asthmatic children and adolescents

EXPERIMENTAL

Children and adolescents aged 6 to 18 years with diagnosed asthma (N=100) for the assessment of PEF and FEV1 variability in asthmatics.

Diagnostic Test: Measurements of PEF and FEV1

Interventions

Measurements of PEF and FEV1DIAGNOSTIC_TEST

Measurements of PEF and FEV1 at home, twice a day (07:00 - 09:00 and 19:00 - 21:00) and for a period of 3 months, using portable spirometers connected to smartphone

Asthmatic children and adolescentsHealthy children and adolescents

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 6 - 18 years
  • No asthma or asthma medication in the last 2 years
  • Normal baseline spirometry
  • Smartphone possession (parents or participants) with ability of internet connection (Wi-Fi or mobile data)
  • Informed written consent (parents, parents \& children \>12 years old)

You may not qualify if:

  • Inability to perform 3 consecutive measurements within the 3-month period of observation
  • Inability to perform 6 measurements in total (3.3% of the anticipated 180 measurements) within the 3-month period of observation
  • Major respiratory events (e.g., asthma attack, severe respiratory infection, chest trauma) or other health-related events that may hamper the performance of lung function measurements (e.g., surgery, trauma) within the 3-month period of observation.
  • Cohort B. Children and adolescents with asthma
  • Age 6 - 18 years
  • Doctor-diagnosed asthma under treatment
  • Smartphone possession (parents or participants) with ability of internet connection (Wi-Fi or mobile data)
  • Informed written consent (parents, parents \& children \>12 years old)
  • Inability to perform 3 consecutive measurements within the 3-month period of observation
  • Inability to perform 6 measurements in total (3.3% of the anticipated 180 measurements) within the 3-month period of observation
  • Major respiratory events (e.g., severe respiratory infection, chest trauma) or other health-related events that may hamper the performance of lung function measurements (e.g., surgery, trauma) within the 3-month period of observation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Respiratory Unit, University Hospital of Patras

Pátrai, Achaia, 26504, Greece

RECRUITING

Related Publications (1)

  • Frima ES, Theodorakopoulos I, Gidaris D, Karantaglis N, Chatziparasidis G, Plotas P, Anthracopoulos M, Fouzas S. Lung Function Variability in Children and Adolescents With and Without Asthma (LUV Study): Protocol for a Prospective, Nonrandomized, Clinical Trial. JMIR Res Protoc. 2020 Aug 7;9(8):e20350. doi: 10.2196/20350.

    PMID: 32763874DERIVED

MeSH Terms

Conditions

Respiratory InsufficiencyAsthma

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sotirios Fouzas

    University of Patras

    STUDY CHAIR

Central Study Contacts

Sotirios Fouzas, MD, PhD

CONTACT

(+30) 2610999980sfouzas@upatras.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

November 9, 2019

First Posted

November 14, 2019

Study Start

January 1, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

GR(1)