Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic... | NCT00522782

Studies
Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

NCT00522782

Sponsor

AAADRS Clinical Research Center

Status

Completed

Last Update Posted

Jan 23, 2009Estimated

Enrollment

16Actual

Phase

Phase 4

Conditions

Asthma

Interventions

Nebulized Budesonide
Nitric Oxide Analyzer

Countries

United States

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

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

Aug 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Aug 28, 2007

First Submission Date that Met QC Criteria

Aug 28, 2007

First Posted Date

Aug 30, 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

Jan 22, 2009

Last Update Posted Date

Jan 23, 2009Estimated

Name	Class
AstraZeneca	INDUSTRY

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

To study the improvement in airway inflammation in children with asthma non-invasively with exhaled breath NO, a marker of inflammation, after therapy with nebulized budesonide as 0.5mg daily.

Detailed Description

Comparisons will be made before and after 2 week therapy of nebulized budesonide in children not on prior anti-inflammatory medications.

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Nebulized budesonide	Drug: Nebulized Budesonide Device: Nitric Oxide Analyzer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nebulized Budesonide	Drug	Pulmicort Respules 0.5mg/2cc	A	Pulmicort Respules 0.5mg/2ml nebulized

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exhaled breath nitric oxide pre- to post treatment		two weeks

Secondary Outcomes

Measure	Description	Time Frame
Spirometry with peak flow measurements and daily diary scores		two weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Asthma diagnosis previously for 6 months
Past asthma medication without change for previous 6 months
Increased NO levels and ability to perform maneuver
ICF signed by parents

Exclusion Criteria:

Systemic steroids in past 60 days,inhaled/nebulized steroids in past 4 weeks
Hospitalization within 3 months
Upper or lower airways active infection or cigarette smoke direct exposure
Use of other asthma medications other than bronchodilators one month prior and during the trial
Noncompliance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miguel J Lanz, MD	Principal Investigator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AAADRS Clinical Research Center		Coral Gables	Florida	33134	United States

Type	Date	Date Unknown
Release	Jan 19, 2012
Reset	Feb 22, 2012

Submission Tracking

Estimated Results First Submitted Date

Jan 19, 2012

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 19, 2012			Feb 22, 2012

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

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided