NCT05748912

Brief Summary

This is a single-center study that will evaluate the safety and tolerability of removal of mucus plugs by bronchoscopy in patients with asthma. This protocol will also plan for the analysis of the features of the mucus plugs removed.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Typical duration for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

January 26, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2022

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

3.2 years

First QC Date

January 29, 2022

Last Update Submit

January 9, 2026

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

  • Change in FEV1 (Forced Expiratory Volume in the 1st second of Forced Expiration)

    We will assess change from baseline FEV1 one week after and six months after removal of mucus plugs by bronchoscopy.

    1 week after and six months after research bronchoscopy.

  • Incidence of Treatment-Emergent Adverse Events

    We will monitor the safety and tolerability of mucus plug removal by bronchoscopy by tracking the number of participants with treatment-related adverse events.

    Up to 1 week after the research bronchoscopy procedure.

Study Arms (1)

Therapeutic bronchoscopy for removal of mucus plugs

EXPERIMENTAL

Protocol A: This protocol will study 10 patients with asthma who have CT (Computed Tomography) evidence of mucus plugs in their airways. Screening data will be reviewed to determine participant eligibility. Participants who meet all eligibility criteria will participate in a bronchoscopy done on one lung for the first 5 participants, and if single lung mucus removal is well tolerated then we will perform bronchoscopies on both lungs for the next 5 participants.

Procedure: Therapeutic bronchoscopy for removal of mucus plugs

Interventions

Therapeutic bronchoscopy for removal of mucus plugsPROCEDURE

Research participants that meet the study inclusion criteria will undergo a research bronchoscopy to remove airway mucus plugs from 1 lung for the first 5 participants, and, if single lung mucus removal is well tolerated, on both lungs for the next 5 participants.

Therapeutic bronchoscopy for removal of mucus plugs

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females between the ages 18 to 70 at the time of visit 1.
  • Clinical history of asthma per patient report or medical record.
  • Pre-bronchodilator FEV1 \< 80% predicted and ≥ 35% predicted
  • CT mucus plug score \> 5.
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

You may not qualify if:

  • Smoking of tobacco or other recreational inhalants in the last month and/or \>10 pack-year smoking history.
  • History of other pulmonary disorders including cystic fibrosis and COPD (Chronic Obstructive Pulmonary Disease).
  • History of unstable cardiovascular disease.
  • BMI \> 45
  • Current use of anticoagulant medications.
  • Upper Respiratory Infection (URI) within the previous 6 weeks
  • Currently pregnant and/or unwillingness to practice medically acceptable birth control or complete abstinence during the study
  • History of COVID-19 (coronavirus disease) in the past 6 months.
  • Protocol B:
  • Males or females between the ages 18 to 80 at the time of visit 1.
  • Undergoing clinically indicated bronchoscopy for removal of mucus plugs.
  • Clinical history of airway disease (including asthma, COPD and bronchiectasis) per patient report or medical record.
  • Written informed consent obtained from subject.
  • Upper Respiratory Infection (URI) in the past 30 days.
  • History of COVID-19 in the past 30 days.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Airway Clinical Research Center

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • DUNNILL MS. The pathology of asthma, with special reference to changes in the bronchial mucosa. J Clin Pathol. 1960 Jan;13(1):27-33. doi: 10.1136/jcp.13.1.27.

    PMID: 13818688BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • John Fahy, MD, MS

    Professor of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: FOCUS protocol A is a single-arm study which means all study participants will receive the same intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2022

First Posted

March 1, 2023

Study Start

January 26, 2022

Primary Completion

March 25, 2025

Study Completion

March 25, 2025

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)