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Cytokine Profile of Allergic Bronchopulmonary Aspergillosis

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03643185
Enrollment
100
Registered
2018-08-22
Start date
2014-12-31
Completion date
2021-05-04
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ABPA

Keywords

cytokine, ABPA, Type 2 immune response, PBMC

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.

Interventions

None listed

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Cytokines levels1 yearThe 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

MeasureTime frameDescription
High attenuation mucus (HAM)OnceIt is defined objectively on a CT scan as having an attenuation value \> 70 Hounsfield units, visually denser than the paraspinal skeletal muscle
Eosinophilia1 yearEqual to or more than 500/μl
FeNO1 yearThe fraction of exhaled nitric oxide
Exacerbation1 yearThe 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 to exacerbation1 yearThe 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 cells1 yearPBMC would be stained immediately or co-cultured with PMA/ionmycin before staining for flow cytometry.
Phenotypes of ABPAOncePatients would be categorized into three phenotypes: ABPA-S (seropositive), ABPA-CB (central bronchiectasis) and ABPA-ORF (other radiologic findings)

Countries

China

Contacts

Primary ContactJin-fu Xu, MD
jfxucn@163.com+86 13321922898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026