Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01121367
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : June 27, 2011
Information provided by:
Beijing Chao Yang Hospital

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).

Condition or disease
Pulmonary Fibrosis Emphysema

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
Actual Enrollment : 82 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema
Study Start Date : May 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

CPFE group

Primary Outcome Measures :
  1. 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 [ Time Frame: six months ]

Secondary Outcome Measures :
  1. pulmonary function tests [ Time Frame: six months ]
  2. fractional exhaled nitric oxide (FENO) [ Time Frame: six months ]

Biospecimen Retention:   Samples Without DNA
whole blood, serum, sputum

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with emphysema,pulmonary fibrosis , combined pulmonary fibrosis and emphysema

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01121367

China, Beijing
Beijing chaoyang hospital-affiliate of captial medical university
Beijing, Beijing, China, 100020
Sponsors and Collaborators
Beijing Chao Yang Hospital
Principal Investigator: kewu huang, MD Beijing Chao Yang Hospital

Responsible Party: kewu Huang, MD, Beijing chaoyang hospital Identifier: NCT01121367     History of Changes
Other Study ID Numbers: KZ200910025007
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: May 2010

Keywords provided by Beijing Chao Yang Hospital:
emphysema; pulmonary fibrosis;chemokine;sputum

Additional relevant MeSH terms:
Pulmonary Fibrosis
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive