The Use of Exhaled Nitric Oxide in Conjunction With the A... | NCT00575445

Studies
The Use of Exhaled Nitric Oxide in Conjunction With the Asthma Control Test to Determine Asthma Control in Pediatric Patients

NCT00575445

Sponsor

Akron Children's Hospital

Status

Terminated

Last Update Posted

Mar 25, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

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

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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Nitric Oxide analyzer not functioning properly

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Dec 2009Actual

Completion Date

Mar 2015Actual

First Submitted Date

Dec 14, 2007

First Submission Date that Met QC Criteria

Dec 14, 2007

First Posted Date

Dec 18, 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

Mar 24, 2015

Last Update Posted Date

Mar 25, 2015Estimated

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 purpose of this study is to determine if exhaled nitric oxide (eNO) levels will be increased in pediatric patients with uncontrolled asthma as determined by the Asthma Control Test (ACT). During the study the investigators will also examine if the combination of eNO and ACT will better predict asthma control that either tool alone when compared to a medical provider's assessment of the patient's asthma control.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
1		Pediatric patients with previously diagnosed asthma

Measure	Description	Time Frame
Exhaled nitric oxide level		One office visit

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of asthma by pediatric pulmonologist
Age 6-18 years

Exclusion Criteria:

Age <6 years or >18 years
history of bronchopulmonary dysplasia
history of cystic fibrosis
history of primary ciliary dyskinesia
current acute asthma exacerbation
current acute viral upper respiratory infection
recent ingestion of nitrate-rich foods

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Pediatric pulmonary clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tiffany L Turner, MD	Pediatric resident at Akron Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Akron Children's Hospital		Akron	Ohio	44308	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12950039	Background	Meyts I, Proesmans M, De Boeck K. Exhaled nitric oxide corresponds with office evaluation of asthma control. Pediatr Pulmonol. 2003 Oct;36(4):283-9. doi: 10.1002/ppul.10317.
14713908	Background	Nathan RA, Sorkness CA, Kosinski M, Schatz M, Li JT, Marcus P, Murray JJ, Pendergraft TB. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004 Jan;113(1):59-65. doi: 10.1016/j.jaci.2003.09.008.

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