Pathogenesis and Inflammatory Phenotype of Allergic Bronc... | NCT07040332

Studies
Pathogenesis and Inflammatory Phenotype of Allergic Bronchopulmonary Aspergillosis

NCT07040332

Sponsor

Qianfoshan Hospital

Status

Recruiting

Last Update Posted

Jul 4, 2025Actual

Enrollment

140Estimated

Phase

Not provided

Conditions

Allergic Bronchopulmonary Aspergillosis (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

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2025Actual

Primary Completion Date

Jul 31, 2027Estimated

Completion Date

Jan 31, 2029Estimated

First Submitted Date

Jun 11, 2025

First Submission Date that Met QC Criteria

Jun 18, 2025

First Posted Date

Jun 27, 2025Actual

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

Jul 1, 2025

Last Update Posted Date

Jul 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qian Qi, Dr., Qianfoshan HospitalPrincipal Investigator

Lead Sponsor

Qianfoshan HospitalOTHER

Collaborators

Name	Class
Shanghai Pulmonary Hospital, Shanghai, China	OTHER
Fudan University	OTHER
Guizhou Provincial People's Hospital	OTHER
The First Hospital of Jilin University

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study aims to reveal the immune and inflammatory regulatory molecular mechanisms related to the progression of allergic bronchopulmonary aspergillosis (ABPA), and to build a precision typing based on inflammation and identify the biomarkers of typing, and to explore the clinical outcomes of different inflammatory phenotypes.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
allergic bronchopulmonary aspergillosis
fungal-sensitized asthma
control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
	Other	No intervention	allergic bronchopulmonary aspergillosis control group fungal-sensitized asthma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total serum IgE		Up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Aspergillus-specific IgE		Up to 12 months
Aspergillus-specific IgG		Up to 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Meets the diagnostic criteria for allergic bronchopulmonary aspergillosis.
Meets the diagnostic criteria for fungal-sensitized asthma.

Exclusion Criteria:

Human immunodeficiency virus infection.
Malignant tumor.
Blood system disease.
autoimmune system disease.
History of pulmonary tuberculosis.
Patients with a history of smoking or still smoking.
Invasive pulmonary fungal disease.
Contraindications electronic bronchoscopy

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

The patients with allergic bronchopulmonary aspergillosis and fungal-sensitized asthma who were treated in several hospitals were included as the study objects, and the relatively normal ones who had no bronchial asthma and no fungal sensitization were matched by gender and age as the control group, and then the cohorts of patients with allergic bronchopulmonary aspergillosis, fungal-sensitized asthma and the control group were established.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qian Qi, Prof.	Contact	+86 13706380314		qiqianqlh@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China	Recruiting	Jinan	Shandong	250014

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001229	Aspergillosis, Allergic Bronchopulmonary

Ancestor Terms

ID	Term
D055732	Pulmonary Aspergillosis
D001228	Aspergillosis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided