AsthmaFOCUSNCT05748912
Lung Function Outcomes Following Removal of Airway Mucus Plugs in Patients With Asthma (FOCUS)
A study testing Therapeutic bronchoscopy for removal of mucus plugs in people with Asthma, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Therapeutic bronchoscopy for removal of mucus plugs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2022to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Males or females between the ages 18 to 80 at the time of visit 1.
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- 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.
Who cannot join
- 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
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- 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:
- Upper Respiratory Infection (URI) in the past 30 days.
- History of COVID-19 in the past 30 days.
- Currently pregnant during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Airway Clinical Research Center
San Francisco, California, 94143
About this study
Official title: Lung Function Outcomes Following Removal of Airway Mucus Plugs in Patients With Asthma
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Therapeutic bronchoscopy for removal of mucus plugs
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic bronchoscopy for removal of mucus plugsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Therapeutic bronchoscopy for removal of mucus plugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 week after the research bronchoscopy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start26 Jan 2022
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Why it stopped: No participants were enrolled in protocol A due to COVID-related restrictions and funding issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- FOCUS protocol A is a single-arm study which means all study participants will receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- John Fahy, MD, MS, Principal investigator, Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748912
- Sponsor's protocol ID
- 21-33420
- Other IDs
- 2P01HL107202-06A1
- Acronym
- FOCUS
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2022
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 13818688
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Function Outcomes Following Removal of Airway Mucus Plugs in Patients With Asthma
- ClinicalTrials.gov ID
- NCT05748912
- Acronym / sponsor ID
- FOCUS / 21-33420
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled in protocol A due to COVID-related restrictions and funding issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- FOCUS protocol A is a single-arm study which means all study participants will receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic bronchoscopy for removal of mucus plugs | Experimental | Procedure: Therapeutic bronchoscopy for removal of mucus plugsProtocol 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic bronchoscopy for removal of mucus plugsResearch 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. | Procedure or surgery | Therapeutic bronchoscopy for removal of mucus plugs |
Primary outcome
Change in FEV1 (Forced Expiratory Volume in the 1st second of Forced Expiration)
Time frame: 1 week after and six months after research bronchoscopy.
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
Time frame: Up to 1 week after the research bronchoscopy procedure.
We will monitor the safety and tolerability of mucus plug removal by bronchoscopy by tracking the number of participants with treatment-related adverse events.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 13818688DUNNILL 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Fahy, MD, MS principal investigator
Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic bronchoscopy for removal of mucus plugs in people with Asthma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 (Forced Expiratory Volume in the 1st second of Forced Expiration) (time frame: 1 week after and six months after research bronchoscopy.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05748912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.