Cytokine Profile of Allergic Bronchopulmonary Aspergillosis

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT03643185

Collaborator

(none)

100

Enrollment

Location

77.1

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
ABPA

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cytokine Profile of Allergic Bronchopulmonary Aspergillosis and Its Relevance to Severity and Exacerbation.

Actual Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

May 4, 2021

Anticipated Study Completion Date :

May 4, 2021

Outcome Measures

Primary Outcome Measures

Cytokines levels [1 year]
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.

Secondary Outcome Measures

Exacerbation [1 year]
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.
High attenuation mucus (HAM) [Once]
It is defined objectively on a CT scan as having an attenuation value > 70 Hounsfield units, visually denser than the paraspinal skeletal muscle
Eosinophilia [1 year]
Equal to or more than 500/μl
FeNO [1 year]
The fraction of exhaled nitric oxide
Phenotypes of ABPA [Once]
Patients would be categorized into three phenotypes: ABPA-S (seropositive), ABPA-CB (central bronchiectasis) and ABPA-ORF (other radiologic findings)
Time to exacerbation [1 year]
The onset date of therapy and the date of the next exacerbation would be recorded to calculate the time to the next exacerbation
Level of different cytokine secreting cells [1 year]
PBMC would be stained immediately or co-cultured with PMA/ionmycin before staining for flow cytometry.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.