This is a randomized controlled trial conducted at the Pediatric Pulmonology Unit of the “Ospedale Pediatrico Bambino Gesù” in Rome, from November 2019 until June 2020. During this period, Italy underwent a period of lockdown due to the Covid-19 pandemic (from March 9 until May 19).

Study participants were preschool children affected by persistent wheeze and treated with preventive low doses of inhaled corticosteroids. The inclusion criteria were children, age between 25 and 72 months, with PSW with either (a) 3 reported episodes in the previous 12 months (b) 1 oral corticosteroids cycle in the previous 6 months; (c) 1 hospitalization for wheezing exacerbations in the previous 12 months. The exclusion criteria were: (1) known anatomic malformations causing a chronic bronchial obstruction; (2) any severe chronic diseases (i.e. cancer, primary immunodeficiency); (3) intention to move away from Rome during the monitoring period. Eligible participants were approached during outpatients visits by a research coordinator and a research nurse, who obtained written consent.

The study provided a recruitment visit at time “0” in November 2019 (V0), a second visit three months later in February 2020 (V1), and a final visit after Italian Covid-19 lockdown in June 2020 (V2) (Fig. 1).

The study design. Legend: Details of the study design: recruitment, randomization and follow-up. Abbreviations: App (Smartphone Application); cACT (Children Asthma Control Test); CQ (Clinical Questionnaire)

At time 0 enrolled participants were simply randomized to either the control or intervention group. All parents were equipped with a written individualized rescue management plan and formally trained for its use. In addition, the intervention group was asked to download the digital application ‘’Asmapp’’ and was instructed on its use. At V1 and V2 all children underwent medical visits, clinical history was collected, the childhood Asthma Control Test (cACT) was completed by children ≥ 4 years of age and a written clinical questionnaire (CQ) was answered by parents/caregivers. Answers to questions on acceptance and usability of the digital support were also collected from the intervention group. Finally, app monitoring data was downloaded, including the registered number of days of app use itself.

A dedicated smartphone application, the so-called ‘’Asmapp’’, was developed with the contribution of Chiesi Foundation. It was designed by a teamwork composed of physicians, nurses, psicologists and parents representative to monitor children’s respiratory symptoms and treatment options adopted. In addition, it provided a section on managing an acute asthma attack, accompanied by video tutorials on how to correctly administer inhaled treatments. Through a dedicated back office the study doctors could prescribe the personalized continuous therapy, but also the correct drugs to manage an asthma attack management, for each specific patient.

At V0, Asmapp was downloaded for free by participants assigned to the intervention group, and they were trained to its use. During the monitoring period, parents/caregivers filled out a daily e-Diary in the App, entering data related to their child’s symptoms, assumption of medication or additional therapies, need for extra visits or hospital admissions, and other parameters. These data were shared also with the physicians and nurses, through the back office allowing an ongoing patients’ monitoring.

A research nurse weekly checked the backup of patients’ e-diaries, going from few minutes to an hour depending on patients’ answers. The caring team got notified if a patient was experiencing frequent exacerbations, needing an earlier review. To support compliance to the e-diary those patients with a low compilation rate were phoned by the study nurse to assist them if they were experiencing difficulties with the app. Assistance was mainly operated by phone and not in person.

Screenshots of the Asmapp user interface and its features can be seen in Fig. 2.

Screenshots of the App (Asmapp). Top left square: login steps; center top square: indicates different options for users (complete your diary, see your scores, asthma exacerbation, tutorial, preferences, logout); top right square: daily diary (did you have fever or cold?); bottom left square: other questions of the daily diary (did you have daily cough, night cough, wheeze, difficult breathing, symptoms that affected daily activities?); bottom middle square (did you need salbutamol?), bottom right square: thanks for completing your diary

This app is not actually available from commercial stores.

The cACT is a widely validated tool designed to assess asthma control in children aged 4–11 years. It is composed of 7 questions (4 child-reported and 3 caregiver-reported) that integrate the child and caregiver’s perspectives on asthma control over the previous 4 weeks. The overall score ranges from 0 (poor control of asthma) to 27 (complete control of asthma) [16].

The CQ was specifically developed by the study authors and it was structured to collect retrospective data over the previous three months. It explored the following 14 items: episodes of wheezing, presence of cough, nighttime symptoms, asthma affecting daily activities, episodes of shortness of breath, need of salbutamol, total days of oral steroids, extra medical examinations, emergency room visits, hospital admissions, lost school days, asthma family perception, need of changing asthma therapy, use of reminders for asthma management.

Finally the intervention group received a short additional questionnaire investigating the satisfaction level of using the app.

Outcomes of the study were to explore the usability, acceptability, feasibility and efficacy of Asmapp. Usability and acceptability of the intervention was determined at follow-up from participants’ opinion about whether the app was easy to use or not and if they would recommend it (Table 1). In addition data on adherence were used to determine the feasibility of an everyday app use. Efficacy of intervention was assessed comparing the results of cACT score and CQ in both groups, searching for respiratory symptoms (Table 2).

Finally, another important outcome was to assess the reliability of the clinical history information collected retrospectively at medical visits, by comparing data recorded daily with the app and the CQ in the intervention group (Table 3).

The sample size was opportunistic as no background data were available to a power calculation. Descriptive statistics were used to analyze baseline data and primary study outcomes. Categorical data were reported as numbers (N) and frequencies (%), while for quantitative data mean/median and standard deviation (SD)/interquartile range (IQR) were calculated. Chi-squared test or Fisher test were used to evaluate the association of categorical data between groups. Taking the paired-nature of the data paired T-test for groups, Wilcoxon and McNemar Chi square were used to compare quantitative variables. A p-value < 0.05 was considered statistically significant. Statistical analyses were performed with SAS 9.4 software.