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

Sponsor

Medical University of Lodz (Other)

Overall Status

Completed

CT.gov ID

NCT00487773

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: budesonide Drug: D3 vitamin Drug: montelukast sodium Drug: salbutamol	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Official Title:

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 budesonide	Drug: budesonide budesonide
Active Comparator: 2 D3 vitamin	Drug: D3 vitamin D3 vitamin
Active Comparator: 3 montelukast sodium	Drug: montelukast sodium montelukast sodium
Active Comparator: 4 salbutamol	Drug: salbutamol salbutamol

Outcome Measures

Primary Outcome Measures

Markers of bone metabolism (from serum and urine) [Baseline and 6 months]

Secondary Outcome Measures

Symptoms score (based on PAQLQ), spirometry [baseline and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics and Allergy, Medical University of Lodz	Lodz		Poland	93-513

Sponsors and Collaborators

Medical University of Lodz

Investigators

Principal Investigator: Malgorzata Olszowiec-Chlebna, MD, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Study Chair: Iwona Stelmach, MD, PhD, Prof, Department of Pediatrics and Allergy, Medical University of Lodz, Poland