Uncontrolled Asthma Self-Scheduler

Basic Criteria: 

• Be 12 to 80 years old

• Have Uncontrolled Asthma 

• Receiving a corticosteroid inhaler treatment 

Answers Must Be No: 

• Are you diagnosed with COPD or other lung diseases such as idiopathic pulmonary fibrosis, or eosinophilic granulomatosis with polyangiitis [EGPA]? 

• Do you have clinical evidence of lung diseases other than asthma within the last 12 months? 

• Have you experienced severe asthma exacerbation, or have you been hospitalized that required treatment with SCS within the last month? 

• Have you experienced an upper or lower respiratory tract infection within the last month? 

• Do you weigh less than 30 kilograms (66.13 lbs.)? 

• Are you a current smoker or did you stop smoking within the last 6 months? 

• Are you a previous smoker with a smoking history of greater than 10 years? 

• Do you have a substance use disorder? 

• Have you had any biologic therapy/immunosuppressant/immunomodulator treatments within the last six months? 

• Have you been exposed to another Investigational Product less than 5 half-lives of it? Or if the half-life is not known, have you been exposed to an Investigational Product within the last 6 months? 

• Are you on OIT or OMT to treat food allergies? 

• Have you had bronchial thermoplasty or planned to begin the therapy? 

• Do you have a history of a systemic hypersensitivity reaction to allergen immunotherapy? 

• Do you have a known history of active TB or non-tuberculous mycobacterial infection, or a history of incompletely treated TB? 

• Do you have a known or suspected immunodeficiency, including history of invasive opportunistic infections (histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, and aspergillosis)? 

• Do you have an active malignancy or history of malignancy within 5 years, except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin? 

• Are you diagnosed with HIV? 

• Are you diagnosed with an active parasitic infection or have a high risk of a parasitic infection?  

• Have you received a live attenuated vaccine within the last month? 

• Have you been on a systemic corticosteroid within the last month, or will you be on one during the study? 

• Have you had either IVIG therapy and/or plasmapheresis within the last 4 weeks? 

• Are you a member or immediate family member of the clinical site team? 

• Are you pregnant or breastfeeding? 

• Are you unwilling to be on a highly effective form of birth control before the study and for at least 12 weeks (about 3 months) after the study?  

• Are you committed to an institution ordered by the judicial or administrative authorities?  

Answers Must Be Yes: 

• Are you 12 to 80 years of age? 

• Have you been on an existing treatment with medium dose ICS/LABA (>250 to 500 μg/day of fluticasone propionate DPI or equivalent for the past 3 months? 

• Do you require a maximum of 3 controllers for your asthma? If yes, have you been on the third controller (such as LAMA, LTRA, 5-lipoxygenase inhibitor, theophylline) for the past 3 months? 

• Do you have a Pre-bronchodilator FEV1 of 50% to 80% of predicted normal? 

• Do you have an ACQ-5 score of ≥1.5? 

• Have you had a history of ≥1 severe exacerbation(s) in the previous year or have experienced at least 1 severe exacerbation event while on a medium dose ICS/LABA? 

• Are you willing and able to comply with clinic visits and study related procedures? 

• Are you willing and able to provide consent and study questionnaires? 

Additional study inclusion and exclusion criteria will apply.  

Additional Information: 

• Compensation may be available, and no insurance is necessary.

• PLEASE NOTE: Please confirm your eligibility before your appointment by calling 352-354-4466.

• If you do not see an available appointment, please call 352-354-4466 for availability.

• Transportation may be available. Call 352-354-4466 for more information.