Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema

Emphysema Clinical Trial

Official title:

Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121367
• Other study ID #: KZ200910025007
• Status: Completed
• Phase: N/A
• First received: May 6, 2010
• Last updated: June 23, 2011
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2010
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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）.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Emphysema
• Fibrosis
• Pulmonary Emphysema
• Pulmonary Fibrosis

Locations

Country	Name	City	State
China	Beijing chaoyang hospital-affiliate of captial medical university	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the expression of CXCR3 in blood by flow cytometry and the chemokine IL-4,IFN-?,CXCL9,CXCL10,CXCL11 and CCL17 in sputum and blood		six months	Yes
Secondary	pulmonary function tests		six months	Yes
Secondary	fractional exhaled nitric oxide (FENO)		six months	Yes