Cytokine Profile of Allergic Bronchopulmonary Aspergillosis

ABPA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03643185
• Other study ID #: 20180627
• Status: Recruiting
• Start date: December 2014
• Est. completion date: May 4, 2021

Study information

• Verified date: March 2021
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Jin-fu Xu, MD
• Phone: +86 13321922898
• Email: jfxucn[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ABPA
• Aspergillosis
• Pulmonary Aspergillosis

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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	Once
Secondary	Eosinophilia	Equal to or more than 500/µl	1 year
Secondary	FeNO	The fraction of exhaled nitric oxide	1 year
Secondary	Phenotypes of ABPA	Patients would be categorized into three phenotypes: ABPA-S (seropositive), ABPA-CB (central bronchiectasis) and ABPA-ORF (other radiologic findings)	Once
Secondary	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	1 year
Secondary	Level of different cytokine secreting cells	PBMC would be stained immediately or co-cultured with PMA/ionmycin before staining for flow cytometry.	1 year