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:

MedlinePlus related topics: Asthma

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 Other Name: budesonide
Active Comparator: 2 D3 vitamin	Drug: D3 vitamin D3 vitamin Other Name: D3 vitamin
Active Comparator: 3 montelukast sodium	Drug: montelukast sodium montelukast sodium Other Name: montelukast sodium
Active Comparator: 4 salbutamol	Drug: salbutamol salbutamol Other Name: 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
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided


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:


Albuterol Budesonide Cholecalciferol Montelukast Vitamins Adrenergic Agents Adrenergic Agonists Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Anti-Asthmatic Agents Anti-Inflammatory Agents Autonomic Agents Bone Density Conservation Agents Bronchodilator Agents Glucocorticoids	Growth Substances Hormone Antagonists Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Leukotriene Antagonists Micronutrients Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Respiratory System Agents Therapeutic Uses Tocolytic Agents

ClinicalTrials.gov processed this record on March 03, 2015