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Bronchoscopy for Mucus Removal in Asthma (FOCUS Trial)
N/A
Recruiting
Led By John Fahy, MD, MS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical history of asthma per patient report or medical record.
Males or females between the ages 18 to 80 at the time of visit 1.
Timeline
Screening 1 day
Treatment Varies
Follow Up 6 months
Awards & highlights
FOCUS Trial Summary
This trial will test if removing mucus plugs with bronchoscopy is safe and tolerable for asthma patients. It will also analyze the features of the removed plugs.
Who is the study for?
The FOCUS trial is for adults aged 18-80 with asthma, who have a CT mucus plug score over 5 and lung function (FEV1) below 80% but above 35% of the predicted value. Participants must not have other lung conditions like COPD or recent infections, no COVID-19 in the past month, no smoking recently or heavy smoking history, and can't be on blood thinners.Check my eligibility
What is being tested?
This study tests how safe and tolerable it is to remove mucus plugs from the airways using bronchoscopy in asthma patients. It's conducted at one center and will also analyze characteristics of the removed mucus plugs.See study design
What are the potential side effects?
Potential side effects may include discomfort during bronchoscopy, bleeding or infection post-procedure, temporary worsening of breathing symptoms, coughing up blood, or reactions to sedation used during bronchoscopy.
FOCUS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a history of asthma.
Select...
I am between 18 and 80 years old.
FOCUS Trial Timeline
Screening ~ 1 day1 visit
Treatment ~ Varies
Follow Up ~ 6 months2 visits
Screening ~ 1 day
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in FEV1 (Forced Expiratory Volume in the 1st second of Forced Expiration)
Incidence of Treatment-Emergent Adverse Events
FOCUS Trial Design
1Treatment groups
Experimental Treatment
Group I: Therapeutic bronchoscopy for removal of mucus plugsExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,503 Previous Clinical Trials
15,236,645 Total Patients Enrolled
34 Trials studying Asthma
20,344 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,625 Total Patients Enrolled
276 Trials studying Asthma
112,541 Patients Enrolled for Asthma
John Fahy, MD, MSPrincipal InvestigatorProfessor of Medicine
2 Previous Clinical Trials
100 Total Patients Enrolled
2 Trials studying Asthma
100 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a cold or similar illness in the last 6 weeks.I have had a cold or similar illness in the last month.I have had COVID-19 in the last 30 days.I have smoked tobacco or other substances in the past month or have a history of smoking more than 10 pack-years.I am currently taking blood thinners.I am between 18 and 80 years old.I have a history of lung conditions like cystic fibrosis or COPD.I have a history of asthma.
Research Study Groups:
This trial has the following groups:- Group 1: Therapeutic bronchoscopy for removal of mucus plugs
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 1 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Asthma Patient Testimony for trial: Trial Name: NCT05748912 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an age restriction for inclusion in this research trial?
"According to the eligibility requirements, individuals wishing to take part in this research must be older than 18 and younger than 80."
Answered by AI
What types of individuals are most suitable to participate in this trial?
"This asthma trial is seeking up to 10 patients between the age of 18 and 80. Those that meet this criteria may be eligible for participation."
Answered by AI
Are volunteers presently being accepted for this experiment?
"Affirmative. According to the clinicaltrials.gov's records, this medical experiment is actively looking for participants since its inception on January 26th 2022 and last edit on February 17th 2023. The study requires 10 people from a single location to fill its slots."
Answered by AI
What is the approximate size of this experiment's participant pool?
"Affirmative. Clinicaltrials.gov highlights this medical trial as actively recruiting patients since it was first published on January 26th 2022 and the latest update is from February 17th 2023. The research requires 10 individuals to be enrolled across one location."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
UCSF Airway Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
Tried other drugs didn’t work. Because my asthma medicines inhalers and breathing treatments aren't helping my breathing issues anymore.
PatientReceived 2+ prior treatments
I've ben on 2 inhalers for my whole life and want to know what options i have other then the generic treatments.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long does it take and is there any compensation involved?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- UCSF Airway Clinical Research Center: < 48 hours
Average response time
- < 2 Days
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