Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema

Capital Medical University

Status: Completed

Conditions: Pulmonary Fibrosis; Emphysema

Study type: Observational

Funder types: Other

Identifiers

NCT01121367

KZ200910025007

Details and patient eligibility

About

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）.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

82 participants in 5 patient groups

Emphysema-alone

CPFE group

IPF-alone

smokers

nonsmokers