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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: budesonide Drug: D3 vitamin Drug: montelukast sodium Drug: salbutamol | Phase 4 |
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 |

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 |
- Markers of bone metabolism (from serum and urine) [ Time Frame: Baseline and 6 months ]
- 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 |
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

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
Poland | |
Department of Pediatrics and Allergy, Medical University of Lodz | |
Lodz, Poland, 93-513 |
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 |
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 |
asthma children inhaled glucocorticosteroids bone metabolism |
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 |