Lung Function Variability in Children and Adolescents With and Without Asthma (LUV Study): Protocol for a Prospective, Nonrandomized, Clinical Trial

Eirini-Sofia Frima; Ilias Theodorakopoulos; Dimos Gidaris; Nikolaos Karantaglis; Grigorios Chatziparasidis; Panagiotis Plotas; Michael Anthracopoulos; Sotirios Fouzas

doi:10.2196/20350

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.

Authors

Eirini-Sofia Frima^{1

2}, Ilias Theodorakopoulos^{2

3}, Dimos Gidaris⁴, Nikolaos Karantaglis⁵, Grigorios Chatziparasidis⁶, Panagiotis Plotas⁷, Michael Anthracopoulos^{1

2}, Sotirios Fouzas^{1

2}

Affiliations

¹ Pediatric Respiratory Unit, University Hospital of Patras, Patras, Greece.
² Pediatric Respiratory Research Group, University of Patras, Patras, Greece.
³ Electronics Laboratory, Department of Physics, University of Patras, Patras, Greece.
⁴ University of Nicosia, Nicosia, Cyprus.
⁵ Pediatric Pulmonology Unit, 3rd Pediatric Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
⁶ Department of Primary Ciliary Dyskinesia, School of Medicine, University of Thessaly, Larissa, Greece.
⁷ Department of Public Health, School of Medicine, University of Patras, Patras, Greece.

PMID: 32763874
PMCID: PMC7442949
DOI: 10.2196/20350

Abstract

Background: Variability analysis of peak expiratory flow (PEF) and forced expiratory volume at 1 second (FEV1) has been used in research to predict exacerbations in adults with asthma. However, there is a paucity of data regarding PEF and FEV1 variability in healthy children and adolescents and those with asthma.

Objective: The objective of this study is the assessment of PEF and FEV1 variability in (1) healthy children and adolescents, to define the normal daily fluctuation of PEF and FEV1 and the parameters that may influence it, and (2) children and adolescents with asthma, to explore the differences from healthy subjects and reveal any specific variability changes prior to exacerbation.

Methods: The study will include 100 healthy children and adolescents aged 6-18 years (assessment of normal PEF and FEV1 variability) and 100 children and adolescents of the same age with diagnosed asthma (assessment of PEF and FEV1 variability in subjects with asthma). PEF and FEV1 measurements will be performed using an ultraportable spirometer (Spirobank Smart; MIR Medical International Research) capable of smartphone connection. Measurements will be performed twice a day between 7 AM and 9 AM and between 7 PM and 9 PM and will be dispatched via email to a central database for a period of 3 months. PEF and FEV1 variability will be assessed by detrended fluctuation and sample entropy analysis, aiming to define the normal pattern (healthy controls) and to detect and quantify any deviations among individuals with asthma. The anticipated duration of the study is 24 months.

Results: The study is funded by the "C. Caratheodory" Programme of the University of Patras, Greece (PN 47014/24.9.2018). It was approved by the Ethics Committee (decision 218/19-03-2019) and the Scientific Board (decision 329/02-04-2019) of the University Hospital of Patras, Greece. Patient recruitment started in January 2020, and as of June 2020, 100 healthy children have been enrolled (74 of them have completed the measurements). The anticipated duration of the study is 24 months. The first part of the study (assessment of lung function variability in healthy children and adolescents) will be completed in August 2020, and the results will be available for publication by October 2020.

Conclusions: Healthy children and adolescents may present normal short- and long-term fluctuations in lung function; the pattern of this variability may be influenced by age, sex, and environmental conditions. Significant lung function variability may also be present in children and adolescents with asthma, but the patterns may differ from those observed in healthy children and adolescents. Such data would improve our understanding regarding the chronobiology of asthma and permit the development of integrated tools for assessing the level of control and risk of future exacerbations.

Trial registration: ClinicalTrials.gov NCT04163146; https://clinicaltrials.gov/ct2/show/NCT04163146.

International registered report identifier (irrid): DERR1-10.2196/20350.

Keywords: adolescents; asthma; children; fluctuation analysis; lung function variability.

©Eirini-Sofia Frima, Ilias Theodorakopoulos, Dimos Gidaris, Nikolaos Karantaglis, Grigorios Chatziparasidis, Panagiotis Plotas, Michael Anthracopoulos, Sotirios Fouzas. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.08.2020.

Associated data

ClinicalTrials.gov/NCT04163146