Pulmonary FibrosisNCT01121367
Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema
An observational study of Pulmonary Fibrosis and Emphysema, run by Beijing Chao Yang Hospital at 1 site in China.
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）. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Fibrosis, Emphysema
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with emphysema，pulmonary fibrosis , combined pulmonary fibrosis and emphysema
Who may be able to join
- IPF-alone group: 10 patients meeting the IPF diagnosis criteria without emphysema.
- CPFE group: 15 patients with CT presentation of concomitant upper-lobe emphysema and lower-lobe fibrosis.
- Emphysema-alone group: 15 patients with their CT diagnosis of emphysema without fibrosis.
- Control: 20 healthy sex- and age-matched volunteers including nonsmokers and smokers. None of the healthy volunteers with a history of respiratory diseases.
Who cannot join
- Age > 90 or < 50
- Treated with corticosteroids or other immunomodulatory drugs
- Some known causes of interstitial lung disease such as collagen vascular disease, drug-induced lung disease, occupational disease.
- An exacerbation in 4 weeks
- Subjects had a history of allergic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing chaoyang hospital-affiliate of captial medical university
Beijing, Beijing Municipality, 100020
About this study
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）.
Read the 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.
- Conditions
- Pulmonary Fibrosis, Emphysema
- Keywords
- emphysema; pulmonary fibrosis;chemokine;sputum
- Medical subject headings
- Pulmonary Fibrosis, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Emphysema-alone | Not described | |
| CPFE group | Not described | |
| IPF-alone | Not described | |
| smokers | Not described | |
| nonsmokers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six months
Secondary outcomes (2)
pulmonary function tests
Measured: six months
fractional exhaled nitric oxide （FENO）
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- kewu huang, MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121367
- Sponsor's protocol ID
- KZ200910025007
- Status last verified
- May 2010
- First submitted
- 6 May 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema
- ClinicalTrials.gov ID
- NCT01121367
- Acronym / sponsor ID
- KZ200910025007
- Conditions
- Pulmonary Fibrosis, Emphysema
- Keywords
- emphysema; pulmonary fibrosis;chemokine;sputum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Emphysema-alone | – | – |
| CPFE group | – | – |
| IPF-alone | – | – |
| smokers | – | – |
| nonsmokers | – | – |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with emphysema，pulmonary fibrosis , combined pulmonary fibrosis and emphysema
Key inclusion criteria (4 listed)
- IPF-alone group: 10 patients meeting the IPF diagnosis criteria without emphysema.
- CPFE group: 15 patients with CT presentation of concomitant upper-lobe emphysema and lower-lobe fibrosis.
- Emphysema-alone group: 15 patients with their CT diagnosis of emphysema without fibrosis.
- Control: 20 healthy sex- and age-matched volunteers including nonsmokers and smokers. None of the healthy volunteers with a history of respiratory diseases.
Key exclusion criteria (5 listed)
- Age > 90 or < 50
- Treated with corticosteroids or other immunomodulatory drugs
- Some known causes of interstitial lung disease such as collagen vascular disease, drug-induced lung disease, occupational disease.
- An exacerbation in 4 weeks
- Subjects had a history of allergic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
pulmonary function tests
Time frame: six months
fractional exhaled nitric oxide （FENO）
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kewu huang, MD principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis and Emphysema, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.