Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 asthma
Started Sep 2007
Shorter than P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2007
CompletedFirst Posted
Study publicly available on registry
June 19, 2007
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedApril 13, 2010
April 1, 2010
1 year
June 18, 2007
April 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Markers of bone metabolism (from serum and urine)
Baseline and 6 months
Secondary Outcomes (1)
Symptoms score (based on PAQLQ), spirometry
baseline and 6 months
Study Arms (4)
1
ACTIVE COMPARATORbudesonide
2
ACTIVE COMPARATORD3 vitamin
3
ACTIVE COMPARATORmontelukast sodium
4
ACTIVE COMPARATORsalbutamol
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Other allergic diseases requiring treatment with glucocorticosteroids
- Other chronic diseases
- Asthma exacerbation
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatrics and Allergy, Medical University of Lodz
Lodz, 93-513, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 18, 2007
First Posted
June 19, 2007
Study Start
September 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
April 13, 2010
Record last verified: 2010-04