Cytokine Profile of Allergic Bronchopulmonary Aspergillosis

• Conditions: ABPA

• Registration Number: NCT03643185
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

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).

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-22
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-21
• Last Update Posted: 2021-03-23
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Level of different cytokine secreting cells	1 year	PBMC would be stained immediately or co-cultured with PMA/ionmycin before staining for flow cytometry.
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
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

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China