Efficacy of Betamethasone Sodium Phosphate in Preventing Recurrent Wheezing and Asthma in Pediatric Patients with Rhinovirus-Induced Acute Wheezing

Trial ID: 2024-515350-25-01
Sponsor: St. Olavs Hospital HF

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Diseases & Conditions

Wheezing Bronchiolitis

Objectives

The primary objective of the study is to evaluate the **efficacy** of systemic corticosteroids in preventing recurrent wheezing and asthma in children experiencing their first severe wheezing episode due to rhinovirus infection. This is stratified by the rhinovirus genome load, which is clinically relevant as it may help tailor treatment strategies to reduce the risk of asthma development in this vulnerable population.

The secondary objectives include determining the number of wheezy episodes, assessing the severity and duration of each acute wheezy episode, evaluating the degree of bronchial hyperreactivity, and measuring the quality of life (QoL) over a 24-month follow-up period. These objectives aim to provide a comprehensive understanding of the long-term impact of the treatment on respiratory health and overall well-being in affected children.

Participants

The clinical trial focuses on evaluating the efficacy of systemic corticosteroids in preventing recurrent wheezing and **asthma** in children experiencing their first severe wheezing episode associated with rhinovirus infection. The study population includes both male and female participants aged between 3 to 24 months. These participants are characterized by their first acute severe wheezing episode, which is defined by specific clinical criteria such as fever, hypoxia, retractions, prolonged expiration, or expiratory rhonchi, and confirmed rhinovirus infection via PCR test. The trial involves a vulnerable population, as it includes young children. However, the total number of participants in the study has not been disclosed by the sponsor. Participants were selected based on their medical condition and the presence of rhinovirus infection, with informed consent obtained from guardians in accordance with ICH GCP and national regulations. Lifestyle considerations such as diet and physical activity are not specified in the available data.

Plans and Procedures

The clinical trial is a **randomized**, double-blind, controlled study designed to evaluate the efficacy of systemic corticosteroids in preventing recurrent wheezing and asthma in children experiencing their first severe wheezing episode due to rhinovirus infection. The trial involves the administration of **dexamethasone** and a placebo, with the primary objective being to assess the time to a new physician-confirmed wheezy episode and the time to fulfill asthma criteria within 24 months after study entry. The study is expected to run from April 2019 to May 2043, with participant involvement lasting up to 24 months.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as age (3-24 months), first-time acute severe wheezing, and evidence of rhinovirus infection. Following the screening, participants will be randomized to receive either the active treatment or placebo. Scheduled follow-up visits will occur throughout the 24-month period to monitor the number, duration, and severity of wheezing episodes, assess pulmonary hyperreactivity, and evaluate quality of life, height, and weight. The end-of-study visit will conclude the participant's involvement, summarizing the outcomes and any adverse events.

Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with the study protocol, or if the investigator deems it necessary for the participant's safety. The trial is conducted in accordance with ICH GCP guidelines and national regulations, ensuring informed consent and cooperation from participants and their guardians. The study aims to provide valuable insights into the long-term benefits of corticosteroid treatment in preventing asthma development in young children with acute wheezing episodes.

Treatment

The clinical trial involves the administration of **DEXAMETHASONE**, an experimental medication, to evaluate its efficacy in preventing recurrent wheezing and asthma in children with rhinovirus-induced wheezing. The active substance in the experimental medication is **BETAMETHASONE SODIUM PHOSPHATE**, a chemical compound. The pharmaceutical form of the medication is coded as PHF00169MIG, and it is administered orally. The maximum daily dose is 6.0 mg, with a total maximum dose of 18.0 mg over a treatment period of up to 3 days. The medication is not formulated specifically for pediatric use.

In addition to the experimental medication, the study utilizes a **placebo** as a comparator treatment. The placebo tablets are identical in appearance to the dexamethasone Abcur 1.0 mg tablets, ensuring blinding in the trial. The placebo is administered in the same manner as the experimental medication, following the same dosing schedule and route of administration. The use of a placebo allows for the assessment of the true efficacy of the experimental treatment by providing a baseline for comparison.

Efficacy

The efficacy of the treatment in the clinical trial titled "Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing - The INSTAR study" will be assessed using both primary and secondary endpoints. The primary endpoints include the time to a new physician-confirmed wheezy episode and the time to fulfill **asthma** criteria, which is defined as the need for a regular controller medication for asthma within 24 months after study entry. These endpoints will provide critical data on the effectiveness of systemic corticosteroids in preventing recurrent wheezing and asthma in children with a first-time severe wheezing episode due to rhinovirus infection.

Secondary endpoints will be evaluated to provide additional insights into the treatment's efficacy. These include the duration and severity of symptoms during the first episode of acute breathing difficulty within 24 months of study entry. At each scheduled follow-up visit within the same period, the number, duration, and severity of episodes with acute breathing difficulty since the start of study medication will be assessed. Additional secondary endpoints include the degree of pulmonary hyperreactivity, quality of life, and measurements of height and weight. These parameters will be collected and analyzed to understand the broader impact of the treatment on the participants' health and well-being over the course of the study.

Inclusion and Exclusion Criteria

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Inclusion Criteria

All of the following conditions must apply to the prospective patient prior to receiving study agent: 1) age 3-24 months, 2) first acute severe wheezing episode, defined as first-time acute breathing difficulty with wheezing ever, appearing less than 7 days from onset of symptoms, in a child referred to hospital, and with one or more of a) fever, b) hypoxia (SAT O2 ≤ 92%), c) retractions (inter-, subcostal), d) prolonged expiration (on auscultation), e) expiratory rhonchi (on auscultation), 3) evidence of rhinovirus infection by PCR test in nasopharyngeal secrete, 4) signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.

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Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria: 1) previous episodes with wheezing, defined as a history of acute breathing difficulty with wheezing in need of treatment at a general practitioner or at hospital, or parental information about similar breathing difficulties, 2) gestational age <37 weeks, 3) chronic illness other than atopy (eczema), 4) previous systemic or inhaled corticosteroid treatment, 5) COVID-19 related disease, 6) participation to another trial, 7) varicella infection or contact during the last 2-3 weeks, 8) need for intensive care unit treatment during the present infection, except for non-invasive respiratory support with high flow nasal cannula ventilation, CPAP or BIPAP, 9) any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).