Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01121367

Enrollment

Registered

2010-05-12

Start date

2010-05-31

Completion date

2011-06-30

Last updated

2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emphysema, Pulmonary Fibrosis

Keywords

emphysema; pulmonary fibrosis;chemokine;sputum

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
the expression of CXCR3 in blood by flow cytometry and the chemokine IL-4,IFN-γ,CXCL9,CXCL10,CXCL11 and CCL17 in sputum and blood	six months

Secondary

Measure	Time frame
pulmonary function tests	six months
fractional exhaled nitric oxide （FENO）	six months

Countries

China

Outcome results