Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma

This study has been completed.
Sponsor:
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00487773
First received: June 18, 2007
Last updated: April 12, 2010
Last verified: April 2010
  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:


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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Budesonide
Montelukast
Cholecalciferol
Vitamins
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014