Ongoing Clinical Trials for Wheezing
Currently, there are 4 ongoing clinical trials investigating treatments for wheezing in children. These studies focus on various approaches, including corticosteroids, immunomodulators, and biological therapies, primarily targeting young children with acute or recurrent wheezing episodes and asthma-related symptoms.
Clinical trial locations
- Czechia
- Finland
- France
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Norway
- Poland
- Spain
- Sweden
Study on Betamethasone Sodium Phosphate to Prevent Asthma in Children with First-time Rhinovirus-induced Wheezing
This trial examines whether systemic corticosteroids can prevent the development of asthma in young children who have experienced their first severe wheezing episode caused by rhinovirus infection. The study specifically tests dexamethasone against a placebo.
Inclusion criteria: Children aged 3 to 24 months experiencing their first severe wheezing episode that started less than 7 days ago are eligible. They must have been referred to a hospital and show at least one of the following signs: fever, low oxygen levels (oxygen saturation of 92% or less), visible retractions during breathing, prolonged expiration time, or rattling sounds when breathing out. A PCR test must confirm the presence of rhinovirus infection from a nasal or throat sample. Parents or guardians must provide signed informed consent.
Exclusion criteria: Children who have previously experienced wheezing or bronchiolitis cannot participate. Those without confirmed rhinovirus infection are also excluded, as are children outside the specified age range or those unable to take systemic corticosteroids.
Study focus: The primary goal is to determine whether early intervention with systemic corticosteroids can reduce the risk of recurrent wheezing and asthma development in young children. Researchers will monitor participants over 24 months, tracking new wheezing episodes, asthma development, symptom duration and severity, lung reactivity, quality of life, and growth measurements.
Investigational treatment: The study tests systemic corticosteroids, which work by reducing inflammation in the airways and calming the immune system, making breathing easier.
Study on Oral Prednisolone and Sucrose for Treating Wheezing Caused by Rhinovirus in Children Under 2 Years Old
This trial investigates whether oral prednisolone sodium phosphate can help children under 2 years old who experience acute wheezing caused by rhinovirus infection recover faster and reduce their need for hospital care.
Inclusion criteria: Children must be between 6 months and 2 years old with acute wheezing diagnosed by an emergency department physician. A nasal swab test must confirm the presence of rhinovirus or another picornavirus. The child must have arrived at the hospital within the past 6 hours and received salbutamol treatment at the emergency department.
Exclusion criteria: Children outside the 6 months to 2 years age range cannot participate. Those without confirmed rhinovirus or picornavirus infection are excluded, as are children with other medical conditions that might interfere with the study or those taking medications that could affect results. Children with allergies to oral prednisolone or whose parents do not consent are also excluded.
Study focus: The main goal is to measure the time between study entry and when the child is deemed fit for discharge from the hospital. Secondary outcomes include total hospital stay length, any need for intensive care, duration of supplemental oxygen use, and monitoring of health indicators such as respiratory and heart rates. Long-term follow-up tracks recurrence of wheezing and any need for asthma medication over up to two years.
Investigational treatment: Oral prednisolone is tested as a steroid medication that reduces inflammation and swelling, potentially improving breathing difficulties in children with rhinovirus-induced wheezing.
Study on the Effectiveness and Safety of OM-85 for Children Aged 6 Months to 5 Years with Recurrent Wheezing
This trial evaluates whether OM-85, made from processed bacterial components, can reduce the frequency of wheezing episodes in children with recurrent wheezing over a six-month treatment period.
Inclusion criteria: Children of any gender aged 6 months to 5 years with recurrent wheezing are eligible. For children not using or only occasionally using inhaled corticosteroids or leukotriene receptor antagonists, they must have had at least 2 wheezing episodes including at least 1 severe episode requiring oral corticosteroids, emergency department visit, or hospitalization, or at least 3 wheezing episodes with one leading to an unscheduled doctor visit in the past year. For children using these medications daily, they must have had at least 1 severe episode or at least 2 episodes with one requiring an unscheduled visit while on daily medication. Children must be up-to-date with vaccinations according to local requirements, and parents or guardians must provide written informed consent.
Exclusion criteria: Children without recurrent wheezing or outside the 6 months to 5 years age range cannot participate. Those with other medical conditions that might interfere with the study, currently taking medications that could affect results, who have recently participated in another clinical trial, or who have known allergies to the study medication or its ingredients are excluded. Children whose parents or guardians do not agree to follow study procedures are also excluded.
Study focus: The study aims to determine if daily OM-85 intake can decrease wheezing episode rates compared to placebo during the six-month treatment period. It will track the number of severe wheezing episodes, episodes requiring oral corticosteroid treatment, and days with wheezing or asthma-like symptoms. Safety assessments will monitor for adverse events and changes in vital signs.
Investigational treatment: OM-85 contains lyophilized bacterial lysates from several bacteria types including Haemophilus influenzae and Streptococcus pneumoniae. It is believed to work as an immunomodulator, enhancing the body’s defense mechanisms against respiratory infections.
Study on the Effects and Safety of Dupilumab for Children Aged 2 to Under 6 with Uncontrolled Asthma or Severe Asthmatic Wheeze
This trial examines whether dupilumab can reduce severe asthma attacks in young children with uncontrolled asthma or frequent severe wheezing over a 52-week treatment period.
Inclusion criteria: Children must be between 2 and less than 6 years old with a diagnosis of asthma or severe wheezing not controlled despite regular use of inhaled medications for at least 3 months. They must meet at least one major criterion from the modified asthma predictive index, such as doctor-diagnosed atopic dermatitis or air allergen sensitivity shown by blood test, or two minor criteria such as wheezing unrelated to colds, eosinophil levels of 4% or more, or allergies to milk, eggs, or peanuts confirmed by blood test. The child’s body weight must be between 5 kg and 30 kg. Parents, caregivers, or legal guardians must be willing to attend clinic visits, follow study procedures, understand study requirements, and be able to complete study questionnaires. Signed informed consent is required.
Exclusion criteria: Children outside the 2 to less than 6 years age range or without uncontrolled asthma or frequent severe attacks cannot participate. Those with other serious health conditions that might interfere with the study, taking medications that could affect results, who have had recent illness or infection, have a history of severe allergic reactions to medications, or are participating in another clinical trial simultaneously are excluded. Children whose parents or guardians do not agree to follow study procedures are also excluded.
Study focus: The study aims to assess whether dupilumab can reduce the number of severe asthma episodes over one year and ensure it is safe and well-tolerated. Regular monitoring tracks response to treatment, adverse effects, and medication concentration in the blood. The trial evaluates overall effectiveness, safety, asthma control, and quality of life over the treatment period.
Investigational treatment: Dupilumab is administered as an injection under the skin and is classified as a monoclonal antibody. It works by blocking interleukin-4 and interleukin-13, proteins involved in the inflammatory response associated with asthma, thereby reducing inflammation in the airways.
Summary
All four ongoing clinical trials focus exclusively on pediatric populations, targeting children from as young as 3 months to 6 years of age. Three of the trials specifically address rhinovirus-induced wheezing, highlighting the significant role this common cold virus plays in childhood respiratory illness. The studies explore different therapeutic approaches: systemic corticosteroids such as dexamethasone and prednisolone for acute episodes, OM-85 as a preventive immunomodulator for recurrent cases, and dupilumab as a biological therapy for severe, uncontrolled asthma and wheezing.
The geographic distribution shows concentration in European countries, with the dupilumab trial being the most widely distributed across nine countries including Czechia, Greece, Hungary, Italy, Germany, Spain, Poland, Netherlands, and France. Nordic countries feature prominently in corticosteroid trials, with Finland, Norway, and Sweden participating in the dexamethasone study, and Finland conducting the prednisolone trial independently. The OM-85 study is limited to Hungary and Poland.
Treatment duration varies significantly across trials, from short-term interventions during acute episodes to long-term monitoring periods of up to two years. This reflects different research goals: immediate symptom relief versus long-term asthma prevention. The trials employ rigorous methodology including placebo controls and double-blind designs to ensure reliable results for these vulnerable young patients.
