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

Medical University of Lodz

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: montelukast sodium; Drug: budesonide; Drug: salbutamol; Drug: D3 vitamin

Study type: Interventional

Funder types: Other

Identifiers

NCT00487773

RNN-87-06-KE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

96 participants in 4 patient groups

1

Active Comparator group

Description:

budesonide

Treatment:

Drug: budesonide

2

Active Comparator group

Description:

D3 vitamin

Treatment:

Drug: D3 vitamin

3

Active Comparator group

Description:

montelukast sodium

Treatment:

Drug: montelukast sodium

4

Active Comparator group

Description:

salbutamol

Treatment:

Drug: salbutamol