Effect of Different Doses of Budesonide on Markers of Bon... | NCT00487773

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

NCT00487773

Sponsor

Medical University of Lodz

Status

Completed

Last Update Posted

Apr 13, 2010Estimated

Enrollment

96Actual

Phase

Phase 4

Conditions

Asthma

Interventions

budesonide
D3 vitamin
montelukast sodium
salbutamol

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jun 18, 2007

First Submission Date that Met QC Criteria

Jun 18, 2007

First Posted Date

Jun 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2010

Last Update Posted Date

Apr 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	budesonide	Drug: budesonide
2	Active Comparator	D3 vitamin	Drug: D3 vitamin
3	Active Comparator	montelukast sodium	Drug: montelukast sodium
4	Active Comparator	salbutamol	Drug: salbutamol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
budesonide	Drug	budesonide	1
D3 vitamin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Markers of bone metabolism (from serum and urine)		Baseline and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Symptoms score (based on PAQLQ), spirometry		baseline and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malgorzata Olszowiec-Chlebna, MD	Department of Pediatrics and Allergy, Medical University of Lodz, Poland	Principal Investigator
Iwona Stelmach, MD, PhD, Prof	Department of Pediatrics and Allergy, Medical University of Lodz, Poland	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics and Allergy, Medical University of Lodz		Lodz		93-513	Poland

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019819	Budesonide
D002762	Cholecalciferol
C093875	montelukast
D000420	Albuterol

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided