Lung Function Outcomes Following Removal of Airway Mucus Plugs in Patients With Asthma (FOCUS)

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 complywith the requirements of the study.

Exclusion Criteria:

• Smoking of tobacco or other recreational inhalants in the last month and/or >10pack-year smoking history.

• History of other pulmonary disorders including cystic fibrosis and COPD (ChronicObstructive 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 birthcontrol 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) perpatient 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.