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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.

Must not have

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).

Timeline

Screening 1 day

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a history of asthma.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have smoked tobacco or other substances in the past month or have a history of smoking more than 10 pack-years.

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I have a history of lung conditions like cystic fibrosis or COPD.

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I am currently taking blood thinners.

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I have had a cold or similar illness in the last month.

Timeline

Screening ~ 1 day1 visit

Treatment ~ Varies

Follow Up ~ 6 months2 visits

Screening ~ 1 day

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 1 day for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Incidence of Treatment-Emergent Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met