AcuteNCT01152424
Usefulness of Exhaled NO in the Differential Diagnosis Acute Eosinophilic Pneumonia and Bacterial Pneumonia
An observational study of Acute and Eosinophilic Pneumonia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute, Eosinophilic Pneumonia
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who visited the study hospital with bilateral pneumonic infiltration.
Who may be able to join
- All patients who visited the study hospital with bilateral pneumonic infiltration.
Who cannot join
- Patients who do not agree with our study protocol
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Armed Forces Capital Hospital
Seongnam, Gyeongi, 482 060
About this study
Official title: Usefulness of Exhaled NO in the Differential Diagnosis Acute Eosinophilic Pneumonia and Community Acquired Pneumonia
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.
- Conditions
- Acute, Eosinophilic Pneumonia
- Keywords
- Acute eosinophilic pneumonia, Exhaled nitric oxide
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute eosinophilic pneumonia | Not described | |
| Community acquired pneumonia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of FeNO in AEP and Community Acquired Pneumonia
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcuteStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152424
- Sponsor's protocol ID
- FeNO in AEP
- Status last verified
- Jun 2011
- First submitted
- 24 Jun 2010
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22016484
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Exhaled NO in the Differential Diagnosis Acute Eosinophilic Pneumonia and Community Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT01152424
- Acronym / sponsor ID
- FeNO in AEP
- Conditions
- Acute, Eosinophilic Pneumonia
- Keywords
- Acute eosinophilic pneumonia, Exhaled nitric oxide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute eosinophilic pneumonia | – | – |
| Community acquired pneumonia | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who visited the study hospital with bilateral pneumonic infiltration.
Key inclusion criteria (1 listed)
- All patients who visited the study hospital with bilateral pneumonic infiltration.
Key exclusion criteria (1 listed)
- Patients who do not agree with our study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The difference of FeNO in AEP and Community Acquired Pneumonia
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Derived from this study: PubMed 22016484Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute and Eosinophilic Pneumonia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of FeNO in AEP and Community Acquired Pneumonia (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01152424, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.