NCT06376617

Brief Summary

This study is to assess the pattern of isolated fungi from the respiratory air way (bronchial tree) from bronchoalvealar lavage (BAL) in asthmatic patients with uncontrolled or difficult to treat asthma

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

April 25, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

April 16, 2024

Last Update Submit

April 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • assess the pattern of isolated fungi from the respiratory air way (bronchial tree) from bronchoalvealar lavage (BAL) in asthmatic patients with uncontrolled or difficult to treat asthma

    BAL will stained by fungal staining with lactophenol stain as well as culture on Sabouraud dextrose agar.

    1 year

Study Arms (1)

Study patern of fungal inection which cause excerbation

OTHER

Take bal through fob and send for fungal stain and culure

Device: fibroptic bronchoscopy

Interventions

take bal through fibrooptic bronchoscopy and send for stain and culcure

Also known as: fugnal stain and culcure
Study patern of fungal inection which cause excerbation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or more.
  • Patients with Uncontrolled bronchial asthma, frequent exacerbations and difficult to treat symptoms despite adherence to medication.

You may not qualify if:

  • Age less than 18 years.
  • Patients who do not give consent for the procedure.
  • Patients with unstable cardiac conditions (recent myocardial infarction, cardiac arrhythmia, etc.)
  • Pregnant women.
  • Patient already on antifungal treatment.
  • Bleeding profile abnormality.
  • patients during acute sever attacks .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: BAL will stained by fungal staining with lactophenol stain as well as culture on Sabouraud dextrose agar.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of chest medicine

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 19, 2024

Study Start

April 25, 2024

Primary Completion

April 20, 2025

Study Completion

May 20, 2025

Last Updated

April 19, 2024

Record last verified: 2024-04