Clinical trial NCT01121367: Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema
Official title: Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Fibrosis
Emphysema
Keywords: emphysema; pulmonary fibrosis;chemokine;sputum
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2010-05-12
Enrollment: 82
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with emphysema，pulmonary fibrosis , combined pulmonary fibrosis and emphysema

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: six months
Secondary outcomes:
measure: pulmonary function tests
timeFrame: six months
measure: fractional exhaled nitric oxide （FENO）
timeFrame: six months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing chaoyang hospital-affiliate of captial medical university
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: kewu huang, MD
role: PRINCIPAL_INVESTIGATOR
References: