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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:
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00487773
First received: June 18, 2007
Last updated: April 12, 2010
Last verified: April 2010
History of Changes

June 18, 2007
April 12, 2010
September 2007
September 2008   (final data collection date for primary outcome measure)
Markers of bone metabolism (from serum and urine) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: Yes ]
Markers of bone metabolism (from serum and urine) [ Time Frame: Baseline and 6 months ]
Complete list of historical versions of study NCT00487773 on ClinicalTrials.gov Archive Site
Symptoms score (based on PAQLQ), spirometry [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
symptoms score (based on PAQLQ), spirometry [ Time Frame: baseline and 6 months ]
Not Provided
Not Provided
 
Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma
Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma - Randomized, Controlled Trial.

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Asthma
  • Drug: budesonide
    budesonide
    Other Name: budesonide
  • Drug: D3 vitamin
    D3 vitamin
    Other Name: D3 vitamin
  • Drug: montelukast sodium
    montelukast sodium
    Other Name: montelukast sodium
  • Drug: salbutamol
    salbutamol
    Other Name: salbutamol
  • Active Comparator: 1
    budesonide
    Intervention: Drug: budesonide
  • Active Comparator: 2
    D3 vitamin
    Intervention: Drug: D3 vitamin
  • Active Comparator: 3
    montelukast sodium
    Intervention: Drug: montelukast sodium
  • Active Comparator: 4
    salbutamol
    Intervention: Drug: salbutamol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
September 2008
September 2008   (final data collection date for primary outcome measure)

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
Both
5 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00487773
RNN-87-06-KE
Yes
Iwona Stelmach MD, PhD, Prof, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Medical Universtity of Lodz
Not Provided
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
Medical Universtity of Lodz
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP