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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Stichting Radboud University Medical Center Nijmegen The Netherlands
Lwgdn Upgnjgaegekz Muqvdwg Cvhjair (rbrmy Leiden The Netherlands
Eojunln Uxdypzwbfdeg Mxsnkib Cugrvlk Rfxuycbph (gtmkzfc Mqf Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.11.2025

Trial locations

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.

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 ID:
2025-522694-11-00
Protocol code:
PaNaMa 12782
Trial Phase:
Therapeutic confirmatory (Phase III)

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