Cytokine Profile of Allergic Bronchopulmonary Aspergillosis

Shanghai Pulmonary Hospital, Shanghai, China100 enrolled

Overview

The main aim of this study is to determine whether the levels of different inflammatory cytokines in the serum and BALF (bronchoalveolar lavage fluid) are relative to the severity and exacerbations of ABPA (allergic bronchopulmonary aspergillosis).

The study would record patients' medical data at baseline and follow them up for different period of time. Updated data would be recorded and blood( or BALF) of the patients would be drawn for tests or stored as whole blood or serum at -80℃ when patients visit the hospital. Then the cytokine (A panel set by the manufacturer) of the serum and BALF would be tested . The secretion ability of peripheral blood mononuclear cells would also be verified. The investigators would then analyze the data and see if any cytokine is relative to the exacerbation or other indicators of the severity of ABPA.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

ABPA

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

For ABPA patients Inclusion Criteria: * Patients diagnosed as allergic bronchopulmonary aspergillosis (ABPA). The diagnosis criteria of ABPA is as following: clinical diagnosis of asthma, elevated total IgE levels (\> 1,000 IU/mL), presence of specific IgE against A fumigatus detected (\> 0.35 kUA/L) or type 1 skin reaction to Aspergillus antigen. Other criteria(at least two of three): Presence of serum IgG antibodies (precipitins) against A. fumigatus; Radiographic pulmonary opacities consistent with ABPA(It might be transient consolidation, nodules, finger-in-glove opacities. Or it could be permanent bronchiectasis and pleuropulmonary fibrosis) Patients who sighed consent forms. For asthma patients: Diagnosis according to GINA. For healthy control: People with ongoing chronic allergic disease such as allergic rhinitis, asthma and allergic dermatitis are excluded. Exclusion Criteria: * Patients who are unwilling to sign the consent form.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Cytokines levels

The levels of different cytokines in the serum or BALF at the enrollment and during follow up. The relation of different cytokines levels and characteristics of ABPA patients would be analyzed.

Time frame: 1 year

Secondary Outcomes

Exacerbation

The worsening of the symptoms of patients, or the new infiltrate of lung under CT scan that is relevant to ABPA, or the elevated serum IgE level.

Time frame: 1 year

High attenuation mucus (HAM)

It is defined objectively on a CT scan as having an attenuation value \> 70 Hounsfield units, visually denser than the paraspinal skeletal muscle

Time frame: Once

Eosinophilia

Equal to or more than 500/μl

Time frame: 1 year

FeNO

The fraction of exhaled nitric oxide

Time frame: 1 year

Phenotypes of ABPA

Patients would be categorized into three phenotypes: ABPA-S (seropositive), ABPA-CB (central bronchiectasis) and ABPA-ORF (other radiologic findings)

Time frame: Once

Time to exacerbation

The onset date of therapy and the date of the next exacerbation would be recorded to calculate the time to the next exacerbation

Time frame: 1 year

Level of different cytokine secreting cells

PBMC would be stained immediately or co-cultured with PMA/ionmycin before staining for flow cytometry.

Central Contacts

Jin-fu Xu, MD

CONTACT

+86 13321922898 jfxucn@163.com

Data from ClinicalTrials.gov

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