Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema

NCT ID: NCT01121367

Last Updated: 2011-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-06-30

Brief Summary

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This study is to evaluate the expression of biological markers in induced sputum and peripheral blood T lymphocytes of patients with combined pulmonary fibrosis and emphysema (CPFE). The features of CPFE would be observed, including pulmonary function tests and fractional exhaled nitric oxide (FENO).

Detailed Description

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A new disease including concomitant upper-lobe emphysema and lower-lobe fibrosis in radiology has been defined as (combined pulmonary fibrosis and emphysema, CPFE). CPFE has distinct clinical characteristics with the emphysema and the pulmonary fibrosis, including gender, age, clinical manifestation, pulmonary function tests and prognosis.

Normally Th1/Th2 is balanced. However, patients with emphysema had a significantly higher expression of Th1. On the other hand, higher expression of Th2 is involved in the development of pulmonary fibrosis. The expressions of Th1 and Th2 were proved to play a central role in pathogenesis of emphysema and pulmonary fibrosis, while are still unknown in patients of combined pulmonary fibrosis and emphysema. The study would observe the Th1/Th2 expression, pulmonary function tests , fractional exhaled nitric oxide (FENO)and other features in CPFE patients.

Conditions

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Pulmonary Fibrosis Emphysema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Emphysema-alone

No interventions assigned to this group

CPFE group

No interventions assigned to this group

IPF-alone

No interventions assigned to this group

smokers

No interventions assigned to this group

nonsmokers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. IPF-alone group: 10 patients meeting the IPF diagnosis criteria without emphysema.
2. CPFE group: 15 patients with CT presentation of concomitant upper-lobe emphysema and lower-lobe fibrosis.
3. Emphysema-alone group: 15 patients with their CT diagnosis of emphysema without fibrosis.
4. Control: 20 healthy sex- and age-matched volunteers including nonsmokers and smokers. None of the healthy volunteers with a history of respiratory diseases.

Exclusion Criteria

1. Age \> 90 or \< 50
2. Treated with corticosteroids or other immunomodulatory drugs
3. Some known causes of interstitial lung disease such as collagen vascular disease, drug-induced lung disease, occupational disease.
4. An exacerbation in 4 weeks
5. Subjects had a history of allergic diseases.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Beijing chaoyang hospital

Principal Investigators

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kewu huang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

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Beijing chaoyang hospital-affiliate of captial medical university

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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KZ200910025007

Identifier Type: -

Identifier Source: org_study_id

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