Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema

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）.

Study Overview

• Status: Completed
• Conditions: Emphysema; Pulmonary Fibrosis

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.

• Study Type: Observational
• Enrollment (Actual): 82

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Beijing chaoyang hospital-affiliate of captial medical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with emphysema，pulmonary fibrosis , combined pulmonary fibrosis and emphysema

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
smokers
Emphysema-alone
CPFE group
IPF-alone
nonsmokers

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Principal Investigator: kewu huang, MD, Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 6, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (Estimate): May 12, 2010

Study Record Updates

• Last Update Posted (Estimate): June 27, 2011
• Last Update Submitted That Met QC Criteria: June 23, 2011
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: emphysema; pulmonary fibrosis;chemokine;sputum
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Fibrosis; Pulmonary Emphysema; Emphysema; Pulmonary Fibrosis
• Other Study ID Numbers: KZ200910025007