Early Diagnosis of Asthma in Young Children | NCT00422747

Studies
Early Diagnosis of Asthma in Young Children

NCT00422747

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Jun 18, 2013Estimated

Enrollment

202Actual

Phase

Not Applicable

Conditions

Asthma

Interventions

beclomethasondipropionate

Countries

Netherlands

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

Jun 2013

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

Apr 2007

Primary Completion Date

Jun 2011Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jan 15, 2007

First Submission Date that Met QC Criteria

Jan 15, 2007

First Posted Date

Jan 17, 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

Jun 17, 2013

Last Update Posted Date

Jun 18, 2013Estimated

Name	Class
The Netherlands Asthma Foundation	OTHER
Stichting Astma Bestrijding, The Netherlands	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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 overall aim of the study is an early asthma diagnosis in young children by the use of non-invasive biomarkers of airway inflammation /oxidative stress in exhaled air, and early lung function measurements

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

202Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
beclomethasondipropionate	Experimental	2 x 100 ug dd for two months, via aerochamber	Drug: beclomethasondipropionate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
beclomethasondipropionate	Drug	2 x 100 ug dd for two months, via aerochamber	beclomethasondipropionate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- definite asthma diagnosis - biomarkers in exhaled breath		6 years of age

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 2-3 years, with recurrent respiratory symptoms suggestive of asthma
Children aged 2-3 years, with no or minor respiratory symptoms

Exclusion Criteria:

Mental retardation
Cardiac anomalies
Congenital malformations
Other diseases of the lungs/airways
Chronic systemic inflammatory diseases like M. Crohn
The inability to perform lung function measurements and/or exhaled air collection

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

4 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edward Dompeling, PhD MD	Dept. of Paediatric Pulmonology, Maastricht University Medical Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Centre		Maastricht	Limburg	5800	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25474185	Derived	Klaassen EM, van de Kant KD, Jobsis Q, van Schayck OC, Smolinska A, Dallinga JW, van Schooten FJ, den Hartog GJ, de Jongste JC, Rijkers GT, Dompeling E. Exhaled biomarkers and gene expression at preschool age improve asthma prediction at 6 years of age. Am J Respir Crit Care Med. 2015 Jan 15;191(2):201-7. doi: 10.1164/rccm.201408-1537OC.
23277518

ID	Term
D001249	Asthma
D004194	Disease

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