NCT07040332

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
33mo left

Started May 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress27%
May 2025Jan 2029

Study Start

First participant enrolled

May 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

2.2 years

First QC Date

June 11, 2025

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total serum IgE

    Up to 12 months

Secondary Outcomes (2)

  • Aspergillus-specific IgE

    Up to 12 months

  • Aspergillus-specific IgG

    Up to 12 months

Study Arms (3)

allergic bronchopulmonary aspergillosis

fungal-sensitized asthma

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China

Jinan, Shandong, 250014, China

RECRUITING

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Condition Hierarchy (Ancestors)

Pulmonary AspergillosisAspergillosisMycosesBacterial Infections and MycosesInfectionsLung Diseases, FungalRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 27, 2025

Study Start

May 10, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

January 31, 2029

Last Updated

July 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations