Clinical trial NCT03643185: Cytokine Profile of Allergic Bronchopulmonary Aspergillosis
Official title: Cytokine Profile of Allergic Bronchopulmonary Aspergillosis and Its Relevance to Severity and Exacerbation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ABPA
Keywords: cytokine
ABPA
Type 2 immune response
PBMC
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ABPA patients who were or would be hospitalized in Shanghai Pulmonary Hospital would be recruited. They would receive standard treatment of ABPA and be asked to visit the clinic again one month later after they start taking glucocorticoids. they are also asked to visit the clinic every three month to monitor the change of serum IgE and their condition. Asthma patients and healthy controls are also enrolled as contrast groups.

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.

Eligibility 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.

Primary outcomes:
measure: Cytokines levels
timeFrame: 1 year
Secondary outcomes:
measure: Exacerbation
timeFrame: 1 year
measure: High attenuation mucus (HAM)
timeFrame: Once
measure: Eosinophilia
timeFrame: 1 year
measure: FeNO
timeFrame: 1 year
measure: Phenotypes of ABPA
timeFrame: Once
measure: Time to exacerbation
timeFrame: 1 year
measure: Level of different cytokine secreting cells
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Jin-fu Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: