Asthma
Conditions
Keywords
asthma, children, inhaled glucocorticosteroids, bone metabolism
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.
Interventions
DRUGbudesonide
budesonide
DRUGD3 vitamin
D3 vitamin
DRUGmontelukast sodium
montelukast sodium
DRUGsalbutamol
salbutamol
Sponsors
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Markers of bone metabolism (from serum and urine) | Baseline and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms score (based on PAQLQ), spirometry | baseline and 6 months |
Countries
Poland
Outcome results
None listed