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

NCT ID: NCT00487773

Last Updated: 2010-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-09-30

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

budesonide

Group Type ACTIVE_COMPARATOR

budesonide

Intervention Type DRUG

budesonide

2

D3 vitamin

Group Type ACTIVE_COMPARATOR

D3 vitamin

Intervention Type DRUG

D3 vitamin

3

montelukast sodium

Group Type ACTIVE_COMPARATOR

montelukast sodium

Intervention Type DRUG

montelukast sodium

4

salbutamol

Group Type ACTIVE_COMPARATOR

salbutamol

Intervention Type DRUG

salbutamol

Interventions

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budesonide

budesonide

Intervention Type DRUG

D3 vitamin

D3 vitamin

Intervention Type DRUG

montelukast sodium

montelukast sodium

Intervention Type DRUG

salbutamol

salbutamol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Principal Investigators

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Malgorzata Olszowiec-Chlebna, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Iwona Stelmach, MD, PhD, Prof

Role: STUDY_CHAIR

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Locations

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Department of Pediatrics and Allergy, Medical University of Lodz

Lodz, , Poland

Site Status

Countries

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Poland

Other Identifiers

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RNN-87-06-KE

Identifier Type: -

Identifier Source: org_study_id

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