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Study of inhaled corticosteroids (beclometasone, fluticasone, budesonide) and salbutamol in children aged 1-6 years with episodic wheezing

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on children with episodic expiratory wheezing, a condition where breathing becomes difficult and produces a whistling sound during exhalation. The research examines the effectiveness of different treatment approaches using inhaled medications called corticosteroids and bronchodilators.

The medications being studied include several types of inhaled corticosteroids: beclometasone dipropionate, fluticasone propionate, and budesonide. These are anti-inflammatory medicines that help reduce swelling in the airways. Another medication being tested is salbutamol, a bronchodilator that helps relax and open up the airways to make breathing easier.

The study compares two different ways of using these medications: one approach involves taking corticosteroids daily for at least 6 weeks along with bronchodilators when needed, while the other approach uses these medications only when symptoms appear. The treatment period lasts for 12 months, during which the effects on breathing symptoms and quality of life will be monitored.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your participation begins with a medical assessment to confirm episodic expiratory wheezing (recurring breathing difficulties with a whistling sound during exhaling).

    The evaluation confirms if you are between 1 and 6 years old and have experienced at least two episodes of wheezing.

  2. Step 2

    Treatment group assignment

    You will be assigned to one of two treatment groups:

    Group 1: Daily inhaled corticosteroids for at least 6 weeks plus bronchodilators when needed

    Group 2: Inhaled corticosteroids and bronchodilators only during symptoms

  3. Step 3

    Medication administration

    The medications you may receive through inhalation include:

    Beclometasone (corticosteroid to reduce airway inflammation)

    Fluticasone (corticosteroid to reduce airway inflammation)

    Budesonide (corticosteroid to reduce airway inflammation)

    Salbutamol (bronchodilator to relieve wheezing symptoms)

  4. Step 4

    Follow-up evaluations

    Your progress will be monitored at two key points:

    First evaluation: After 1 month of treatment

    Final evaluation: After 12 months of treatment

    During these evaluations, your symptom control and quality of life will be assessed

  5. Step 5

    Study completion

    The study continues until May 31, 2029

    Your participation helps evaluate which treatment approach is more effective for managing episodic wheezing in young children

Who can join the trial?

7 criteria

  • Child must be between 1 and 6 years old (at least 1 year old but not yet 6 years old)
  • Child must have had at least two episodes of wheezing (difficulty breathing with a whistling sound when breathing out)
  • Child must have visited their family doctor or after-hours medical service for wheezing problems
  • Both boys and girls can participate in the study
  • Child must be under the care of a general practitioner (family doctor)
  • Parent or legal guardian must be willing to give permission for the child to participate
  • Parent or legal guardian must be able to attend follow-up visits over a 12-month period

Who cannot join the trial?

14 criteria

  • Children under 1 year old or over 6 years old
  • Previous diagnosis of asthma (long-term lung condition causing breathing difficulties)
  • Use of inhaled corticosteroids (anti-inflammatory inhaler medications) in the past 6 months
  • Having other chronic respiratory conditions besides wheezing
  • Known allergies to any of the study medications
  • Participation in other clinical trials within the last 30 days
  • Presence of serious heart conditions
  • Having a chronic illness (long-term health condition) that might affect breathing
  • Children who cannot properly use inhalers even with assistance
  • History of life-threatening allergic reactions
  • Children with developmental delays that might affect their ability to participate
  • Inability of parents/guardians to understand and follow study instructions
  • Known immunodeficiency (weakened immune system)
  • Children who have required hospitalization for breathing problems in the past 3 months
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Investigated drugs

  • Inhaled corticosteroids (ICS)

    are medications that help reduce inflammation in the airways. They are inhaled directly into the lungs to help control and prevent wheezing symptoms. These medications work by decreasing swelling and mucus production in the airways, making breathing easier.

  • Bronchodilators

    are medications that help relax and open up the airways quickly when wheezing occurs. They provide quick relief by relaxing the muscles around the airways, making it easier to breathe. These medications are typically used as needed when symptoms appear.

What is already known about the treatment

  • Inhaled Corticosteroids (ICS)

    A type of anti-inflammatory medication that is administered through inhalation directly into the airways using special inhalers or nebulizers. These medications are widely recognized in medical literature as a primary treatment for various respiratory conditions, particularly focusing on reducing airway inflammation in children with episodic expiratory wheezing. The medication works at the molecular level by suppressing inflammatory responses in the airways, reducing swelling, and decreasing mucus production, which helps to prevent and control wheezing episodes. These medications belong to the corticosteroid class of drugs and are commonly prescribed as a preventive treatment for respiratory conditions in young children.

  • Bronchodilators

    A class of medications that are inhaled through special devices to provide quick relief from breathing difficulties by relaxing and opening the airways. These medications are well-established in medical practice for treating acute episodes of wheezing and shortness of breath, working within minutes by relaxing the smooth muscles around the airways. At the molecular level, bronchodilators activate specific receptors that cause airway muscles to relax, making breathing easier and providing rapid symptom relief. They belong to the beta-2 agonist pharmacological class and are typically used as rescue medication during acute wheezing episodes.

Investigated diseases

Episodic Expiratory Wheezing - A respiratory condition that primarily affects young children, characterized by recurring episodes of wheezing sounds during breathing out. The wheezing occurs in distinct episodes with symptom-free periods in between. During an episode, the airways become temporarily narrow, making it harder to breathe and causing a whistling sound when exhaling. The condition often appears in response to viral infections or environmental triggers, and symptoms typically include coughing and breathing difficulties. Some children may experience these episodes particularly during physical activity or at night.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-522694-11-00Protocol codePaNaMa 12782Estimated enrolment285 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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