Cytokine Profile of Allergic Bronchopulmonary Aspergillosis | NCT03643185

Studies
Cytokine Profile of Allergic Bronchopulmonary Aspergillosis

NCT03643185

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Status

Unknown status

Last Update Posted

Mar 23, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

ABPA

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014Actual

Primary Completion Date

May 4, 2021Estimated

Completion Date

May 4, 2021Estimated

First Submitted Date

Aug 21, 2018

First Submission Date that Met QC Criteria

Aug 21, 2018

First Posted Date

Aug 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2021

Last Update Posted Date

Mar 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
High attenuation mucus (HAM)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample