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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00487773
First Posted: June 19, 2007
Last Update Posted: April 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical Universtity of Lodz
  Purpose
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 Intervention Phase
Asthma Drug: budesonide Drug: D3 vitamin Drug: montelukast sodium Drug: salbutamol Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

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

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

Enrollment: 96
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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
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
Poland
Department of Pediatrics and Allergy, Medical University of Lodz
Lodz, Poland, 93-513
Sponsors and Collaborators
Medical Universtity 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
  More Information

Responsible Party: Iwona Stelmach MD, PhD, Prof, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
ClinicalTrials.gov Identifier: NCT00487773     History of Changes
Other Study ID Numbers: RNN-87-06-KE
First Submitted: June 18, 2007
First Posted: June 19, 2007
Last Update Posted: April 13, 2010
Last Verified: April 2010

Keywords provided by Medical Universtity of Lodz:
asthma
children
inhaled glucocorticosteroids
bone metabolism

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Cholecalciferol
Budesonide
Albuterol
Montelukast
Micronutrients
Growth Substances
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