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

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ClinicalTrials.gov Identifier: NCT00487773
Recruitment Status : Completed
First Posted : June 19, 2007
Last Update Posted : April 13, 2010
Sponsor:
Information provided by:
Medical University of Lodz

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : September 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Markers of bone metabolism (from serum and urine) [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures :
  1. Symptoms score (based on PAQLQ), spirometry [ Time Frame: baseline and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487773


Locations
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Poland
Department of Pediatrics and Allergy, Medical University of Lodz
Lodz, Poland, 93-513
Sponsors and Collaborators
Medical University of Lodz
Investigators
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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
More Information
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Responsible Party: Iwona Stelmach MD, PhD, Prof, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
ClinicalTrials.gov Identifier: NCT00487773    
Other Study ID Numbers: RNN-87-06-KE
First Posted: June 19, 2007    Key Record Dates
Last Update Posted: April 13, 2010
Last Verified: April 2010
Keywords provided by Medical University of Lodz:
asthma
children
inhaled glucocorticosteroids
bone metabolism
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cholecalciferol
Budesonide
Albuterol
Montelukast
Vitamins
Micronutrients
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action