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Study of the Etiology and Immunological Pathogenesis in Acute Exacerbation of Idiopathic Pulmonary Fibrosis (AE-IPF)

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ClinicalTrials.gov Identifier: NCT02509364
Recruitment Status : Unknown
Verified July 2015 by Huiping Li, Shanghai Pulmonary Hospital, Shanghai, China.
Recruitment status was:  Enrolling by invitation
First Posted : July 28, 2015
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Huiping Li, Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary:

Idiopathic pulmonary fibrosis (IPF) is a highly heterogeneous and lethal pathological process with limited therapeutic options, which is the most common and severe of the idiopathic interstitial pneumonias (IIPs). During the past 20 years, the incidence of IPF increased significantly. Most of IPF patients show a median survival time of 2-3 years after diagnosis. Five-year survival rate is 30%-50%. It's difficult to diagnose in the early stage of IPF. Once the patients go to hospital, it's already in the late stage. Now there is no effective therapy except lung transplant for IPF in clinical application.

Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a fatal condition with high mortality (over 80%). Its etiology and pathogenesis remain unknown. There is a lack of effective treatment for it. Based on the investigators' long-term clinical observation, most cases of AE-IPF initially got "common cold" and had coryza, more cough, nasal obstruction,rhinorrhea, sore throat, some patients had fever, headache, and etc. Some of these patients' condition developed very rapidly and then became very severe similar to the situation of acute respiratory distress syndrome (ARDS). Why these AE-IPF patients were so hypersensitive to "cold"? What were the immunologic and pathological mechanisms of their lung lesions after patients exposed to "common cold"? How to effectively offer interventional treatment for AE-IPF? All the above questions are yet to be explained clearly.

In the investigators' previous retrospective study, the investigators found that there were some obviously imbalanced immune responses in IPF patients, including increased cluster of differentiation 4 (CD4) T cell population, immunoglobulin and complements. The investigators also found highly expressed inflammatory cytokines (IL-17, MIG and IL-9) and high detection rates of pathogens in AE-IPF patients, especially serum immunoglobulin M (IgM) antibody of some respiratory virus. These findings provide a strong suggestion that there are some imbalance of immunologic function in IPF and there are relationship between AE-IPF and infection, especially "Cold" virus infection might be a key trigger for AE-IPF.


Condition or disease Intervention/treatment
Interstitial Lung Diseases Other: No intervention

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Retrospective
Study Start Date : August 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : September 2017


Group/Cohort Intervention/treatment
AE-IPF

Diagnosis criteria for AE-IPF:

  • Diagnosed IPF patient experiences unexplained dyspnea within 1 month
  • With objective evidence of hypoxia and new onset of pulmonary infiltration based on imaging examination
  • With other diagnosis like pulmonary embolism, pneumothorax or heart failure excluded.
Other: No intervention
Stable-IPF

Diagnosis criteria for Stable-IPF:

  • Exclusion of other known causes of ILDs
  • Presence of a usual interstitial pneumonitis (UIP) pattern on high-resolution computed tomography (HRCT)
  • Specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to surgical lung biopsy.
Other: No intervention
Health control
Healthy volunteer
Other: No intervention



Primary Outcome Measures :
  1. Virus RNA by pathogen test chip and second generation sequencing in AE-IPF [ Time Frame: up to 30 weeks ]
    Testing of pathogen nucleic acid chips:Based on PathGEN® Pathogen Chip Kit (PathGEN Dx, Singapore). Next Generation Sequencing (NGS) has become the powerful tool in pathogen identification based on its rapidness and sensitivity. The final report will provide the species classification of the bacteria and viruses, as well as corresponding designator.

  2. Macrophage phenotype and function [ Time Frame: up to 30 weeks ]
    Subtype and functional testing on phenotype and function of Macrophage cell in IPF/AE-IPF patients.

  3. Dendritic cell (DC) phenotype and function [ Time Frame: up to 30 weeks ]
    Subtype and functional testing on phenotype and function of DC in IPF/AE-IPF patients.

  4. T cell phenotype and function [ Time Frame: up to 30 weeks ]
    Subtype and functional testing on phenotype and function of T cell in IPF/AE-IPF patients.

  5. B cell phenotype and function [ Time Frame: up to 30 weeks ]
    Subtype and functional testing on phenotype and function of B cell in IPF/AE-IPF patients.

  6. Expression of IL-17 in AE-IPF [ Time Frame: up to 30 weeks ]
    The investigators will evaluate the expression of IL-17 by proteomics in IPF/AE-IPF patients.

  7. Expression of MIG in AE-IPF [ Time Frame: up to 30 weeks ]
    The investigators will evaluate the expression of MIG by proteomics in IPF/AE-IPF patients.


Biospecimen Retention:   Samples With DNA
Sputum, throat swab, BALF and blood will be collected in this study.


Information from the National Library of Medicine

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Ages Eligible for Study:   54 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subject cohorts: Cohort 1: Stable IPF group (n>150); Cohort 2: AE-IPF group (n>50); Cohort 3: healthy control group (n>100). All the IPF patients have been enrolled according to relevant diagnosis criteria. The criteria of AE-IPF include: diagnosed IPF patient experiences unexplained dyspnea within 1 month, with objective evidence of hypoxia and new onset of pulmonary infiltration based on imaging examination, and with other diagnosis like pulmonary embolism, pneumothorax or heart failure excluded.Serial observation of the change of pathogens based on at least two times of sample collection. Healthy control group recruits healthy population based on physical exam, with no definite respiratory disease and normal chest X ray results.
Criteria

Inclusion Criteria:

Clinical diagnosis of IPF:

  • Exclusion of other known causes of ILDs
  • Presence of a UIP pattern on HRCT
  • Specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to surgical lung biopsy.

Clinical diagnosis of AE-IPF:

  • Diagnosed IPF patient experiences unexplained dyspnea within 1 month
  • With objective evidence of hypoxia and new onset of pulmonary infiltration based on imaging examination
  • With other diagnosis like pulmonary embolism, pneumothorax or heart failure excluded.

Exclusion Criteria:

-Not applicable.


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 ClinicalTrials.gov identifier (NCT number): NCT02509364


Locations
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China, Shanghai
Shanghai Pulmonary Hospital, Tongji University
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Principal Investigator: Huiping Li, MD,PhD Shanghai Pulmonary Hospital, Tongji University, Shanghai, China
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Responsible Party: Huiping Li, Chief Physician, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT02509364    
Other Study ID Numbers: SPH150715
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by Huiping Li, Shanghai Pulmonary Hospital, Shanghai, China:
AE-IPF
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases