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Completed

NCT Number: NCT00487773

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatrics and Allergy, Medical University of Lodz

Lodz, 93-513, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

budesonide

D3 vitamin

Drug

D3 vitamin

montelukast sodium

Drug

montelukast sodium

Salbutamol

Drug

salbutamol

Primary outcomes

  1. Markers of bone metabolism (from serum and urine)

    Time frame: Baseline and 6 months

Secondary outcomes

  1. Symptoms score (based on PAQLQ), spirometry

    Time frame: baseline and 6 months

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 19, 2007
Registry last updated
Apr 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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