Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma
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| ClinicalTrials.gov Identifier: NCT00487773 |
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Recruitment Status
:
Completed
First Posted
: June 19, 2007
Last Update Posted
: April 13, 2010
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Sponsor:
Medical Universtity of Lodz
Information provided by:
Medical Universtity of Lodz
- Study Details
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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 |
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 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
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
budesonide
|
Drug: budesonide
budesonide
|
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Active Comparator: 2
D3 vitamin
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Drug: D3 vitamin
D3 vitamin
|
|
Active Comparator: 3
montelukast sodium
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Drug: montelukast sodium
montelukast sodium
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|
Active Comparator: 4
salbutamol
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Drug: salbutamol
salbutamol
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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 ]
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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
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 |
| 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 Posted: | June 19, 2007 Key Record Dates |
| Last Update Posted: | April 13, 2010 |
| Last Verified: | April 2010 |
Keywords provided by Medical Universtity of Lodz:
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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 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 |