Back to resultsLung Function Outcomes Following Removal of Airway Mucus Plugs in Patients With Asthma (FOCUS) (FOCUS)
Primary Purpose
Asthma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic bronchoscopy for removal of mucus plugs
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Protocol A: Inclusion Criteria: 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. Exclusion Criteria: 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: Inclusion Criteria: 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. Exclusion Criteria: Upper Respiratory Infection (URI) in the past 30 days. History of COVID-19 in the past 30 days. Currently pregnant during the study.
Sites / Locations
- UCSF Airway Clinical Research CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Therapeutic bronchoscopy for removal of mucus plugs
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05748912
First Posted
January 29, 2022
Last Updated
February 17, 2023
Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05748912
Brief Title
Lung Function Outcomes Following Removal of Airway Mucus Plugs in Patients With Asthma (FOCUS)
Acronym
FOCUS
Official Title
Lung Function Outcomes Following Removal of Airway Mucus Plugs in Patients With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
January 26, 2025 (Anticipated)
Study Completion Date
January 26, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The investigators' research shows that a large subgroup of asthma patients have mucus plugs, and quantification of these plugs using a bronchopulmonary segment-based scoring system reveals a strong negative correlation between the CT (Computed Tomography) mucus plug score and FEV1 (Forced Expiratory Volume at 1 second). The FOCUS study is a single-center study that has the overarching goal to explore the biology of airway mucus plugs in asthma.
Through the FOCUS study, the investigators will initially explore the safety and tolerability of bronchoscopic removal of airway mucus plugs in patients with asthma and mucus plugs. They will then evaluate potential improvements in lung function outcomes in a dose-dependent manner (i.e., by removing mucus plugs from one lung vs both lungs). A secondary objective of the FOCUS study is to perform detailed cellular and molecular analyses of mucus and epithelial cells from airways impacted with mucus. With these biospecimens, the investigators intend to extend their preliminary findings that mucus plugged airways are characterized by intense type 2 inflammation, determine the mechanisms of epithelial and immune cell reprogramming, as well as how cellular reprogramming affects the promotion and persistence of type 2 airway inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
FOCUS protocol A is a single-arm study which means all study participants will receive the same intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic bronchoscopy for removal of mucus plugs
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Therapeutic bronchoscopy for removal of mucus plugs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in FEV1 (Forced Expiratory Volume in the 1st second of Forced Expiration)
Description
We will assess change from baseline FEV1 one week after and six months after removal of mucus plugs by bronchoscopy.
Time Frame
1 week after and six months after research bronchoscopy.
Title
Incidence of Treatment-Emergent Adverse Events
Description
We will monitor the safety and tolerability of mucus plug removal by bronchoscopy by tracking the number of participants with treatment-related adverse events.
Time Frame
Up to 1 week after the research bronchoscopy procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Protocol A:
Inclusion Criteria:
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.
Exclusion Criteria:
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:
Inclusion Criteria:
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.
Exclusion Criteria:
Upper Respiratory Infection (URI) in the past 30 days.
History of COVID-19 in the past 30 days.
Currently pregnant during the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Orain, BS
Phone
415-502-3472
Email
xavier.orain@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John Fahy, MD, MS
Phone
415-476-9940
Email
john.fahy@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Fahy, MD, MS
Organizational Affiliation
Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Airway Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Orain, BS
Phone
415-502-3472
Email
xavier.orain@ucsf.edu
First Name & Middle Initial & Last Name & Degree
John Fahy, MD, MS
Phone
415-476-9940
Email
john.fahy@ucsf.edu
First Name & Middle Initial & Last Name & Degree
John Fahy, MD, MS
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
13818688
Citation
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.
Results Reference
background
Learn more about this trial
Lung Function Outcomes Following Removal of Airway Mucus Plugs in Patients With Asthma (FOCUS)
We'll reach out to this number within 24 hrs