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

Asthma Clinical Trial

Official title:

Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma - Randomized, Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487773
• Other study ID #: RNN-87-06-KE
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2007
• Last updated: April 12, 2010
• Start date: September 2007
• Est. completion date: September 2008

Study information

• Verified date: April 2010
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• budesonide
budesonide
• D3 vitamin
D3 vitamin
• montelukast sodium
montelukast sodium
• salbutamol
salbutamol

Locations

Country	Name	City	State
Poland	Department of Pediatrics and Allergy, Medical University of Lodz	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Markers of bone metabolism (from serum and urine)		Baseline and 6 months	Yes
Secondary	Symptoms score (based on PAQLQ), spirometry		baseline and 6 months	Yes