Cytokine Profile of Allergic Bronchopulmonary Aspergillosis
1 other identifier
observational
100
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 21, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2021
CompletedMarch 23, 2021
March 1, 2021
6.4 years
August 21, 2018
March 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Exacerbation
1 year
High attenuation mucus (HAM)
Once
Eosinophilia
1 year
FeNO
1 year
Phenotypes of ABPA
Once
- +2 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients who are unwilling to sign the consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Biospecimen
Bronchoalveolar lavage fluid, serum and whole blood.
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-fu Xu, MD
Shanghai Pulmonary Hospital, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Respiratory Medicine
Study Record Dates
First Submitted
August 21, 2018
First Posted
August 22, 2018
Study Start
December 1, 2014
Primary Completion
May 4, 2021
Study Completion
May 4, 2021
Last Updated
March 23, 2021
Record last verified: 2021-03