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Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema

This study has been completed.
Sponsor:
Information provided by:
Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT01121367
First received: May 6, 2010
Last updated: June 23, 2011
Last verified: May 2010
History of Changes
  Purpose

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
Pulmonary Fibrosis
Emphysema

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Chao Yang Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pulmonary function tests [ Time Frame: six months ] [ Designated as safety issue: Yes ]
  • fractional exhaled nitric oxide （FENO） [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

whole blood, serum, sputum


Enrollment: 82
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Emphysema-alone
CPFE group
IPF-alone
smokers
nonsmokers

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

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121367

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

No publications provided

Responsible Party: kewu Huang, MD, Beijing chaoyang hospital
ClinicalTrials.gov Identifier: NCT01121367     History of Changes
Other Study ID Numbers: KZ200910025007
Study First Received: May 6, 2010
Last Updated: June 23, 2011
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Fibrosis
Pulmonary Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013