Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT00487773
- Lead Sponsor
- Medical University of Lodz
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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
- Other allergic diseases requiring treatment with glucocorticosteroids
- Other chronic diseases
- Asthma exacerbation
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 D3 vitamin D3 vitamin 3 montelukast sodium montelukast sodium 4 salbutamol salbutamol 1 budesonide budesonide
- Primary Outcome Measures
Name Time Method Markers of bone metabolism (from serum and urine) Baseline and 6 months
- Secondary Outcome Measures
Name Time Method Symptoms score (based on PAQLQ), spirometry baseline and 6 months
Trial Locations
- Locations (1)
Department of Pediatrics and Allergy, Medical University of Lodz
🇵🇱Lodz, Poland