Usefulness of Exhaled NO in the Differential Diagnosis Ac... | NCT01152424

Studies
Usefulness of Exhaled NO in the Differential Diagnosis Acute Eosinophilic Pneumonia and Bacterial Pneumonia

NCT01152424

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Jun 8, 2011Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Acute
Eosinophilic Pneumonia

Interventions

Not provided

Countries

South Korea

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 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Dec 2011Estimated

First Submitted Date

Jun 24, 2010

First Submission Date that Met QC Criteria

Jun 28, 2010

First Posted Date

Jun 29, 2010Estimated

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 7, 2011

Last Update Posted Date

Jun 8, 2011Estimated

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

Acute eosinophilic pneumonia (AEP) is diagnosed by cell count analysis of bronchoalveolar lavage fluid. However, the performance of bronchoscopy is not easy for patients with AEP, because they usually have hypoxia. Exhaled nitric oxide (FeNO) is usually elevated in the patients with eosinophilic inflammation such as asthma, but there is no previous studies FeNO in the patients with AEP. Investigators hypothesized that FeNO elevated significantly in patients with AEP, and FeNO can be used as non-invasive diagnostic method in patients who are clinically suspected with AEP, especially when the performance of bronchoscopy is difficult.

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

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The difference of FeNO in AEP and Community Acquired Pneumonia		Six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients who visited the study hospital with bilateral pneumonic infiltration.

Exclusion Criteria:

Patients who do not agree with our study protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients who visited the study hospital with bilateral pneumonic infiltration.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Armed Forces Capital Hospital		Seongnam	Gyeongi	482 060	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22016484	Derived	Lee JE, Rhee CK, Lim JH, Lee SM, Shim YS, Lee CT, Won Lee S. Fraction of exhaled nitric oxide in patients with acute eosinophilic pneumonia. Chest. 2012 May;141(5):1267-1272. doi: 10.1378/chest.11-1303. Epub 2011 Oct 20.

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D017681	Hypereosinophilic Syndrome
D004802	Eosinophilia