Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma

Medical University of Lodz96 enrolled

Overview

The purpose of the trial is to check if inhaled glucocorticosteroids (iGCS) have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.

Asthma is the most prevalent chronic disease of respiratory tract, the largest frequency is noticed in children. iGCS are the basic group of drugs in asthma, because of inflammatory character of disease. All iGCS are absorbed to the systemic circulation (small amounts) despite of local exposition in lungs and possess systemic effects. The purpose of trial is to check if iGCS have influence on bone condition (if iGCS increases risk of osteoporosis and bone fraction) in children with asthma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Asthma

Interventions

budesonideDRUG

budesonide

D3 vitaminDRUG

D3 vitamin

montelukast sodiumDRUG

montelukast sodium

salbutamol

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Allergic only to house dust mites * Never treated chronically (longer than at least 3 months) with anti-asthmatic drugs * Newly-diagnosed or non-treated asthma * Must be able to inhale drugs Exclusion Criteria: * Other allergic diseases requiring treatment with glucocorticosteroids * Other chronic diseases * Asthma exacerbation * Pregnancy

Locations (1)

Department of Pediatrics and Allergy, Medical University of Lodz

Lodz, Poland

Outcomes

Primary Outcomes

Markers of bone metabolism (from serum and urine)

Time frame: Baseline and 6 months

Secondary Outcomes

Symptoms score (based on PAQLQ), spirometry

Time frame: baseline and 6 months

Data from ClinicalTrials.gov

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