Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma - Full Text View

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 Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Cholecalciferol Albuterol Levalbuterol Levalbuterol hydrochloride Albuterol sulfate Budesonide Montelukast sodium Montelukast Levalbuterol tartrate

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Symptoms score (based on PAQLQ), spirometry [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]


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


Ages Eligible for Study:	5 Years to 18 Years (Child, Adult)
Genders Eligible for Study:	Both
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

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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	June 18, 2007
Last Updated:	April 12, 2010
Health Authority:	Poland: Ministry of Health

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

ClinicalTrials.gov processed this record on September 28, 2016