Escitalopram in Asthma Patients With Frequent Exacerbation

A 26-week, randomized, double-blind, placebo-controlled trial of escitalopram will be conducted in 105 people with moderate to severe persistent asthma who, despite treatment with medium to high dose inhaled corticosteroids and long-acting beta-agonist therapy, had ≥ 3 asthma exacerbations in the past year. The primary outcome measure will be the number of times systemic corticosteroids are given for an asthma exacerbation with the Asthma Control Questionnaire as a secondary outcome measure. Mood and anxiety symptoms and functioning will be assessed as will the role of psychological asthma triggers on asthma symptom exacerbation. Serum IL-6 and peripheral eosinophil levels as well as fractional exhaled nitric oxide (FeNO) will be assessed. Thus, psychological/psychiatric and biological or immune mechanisms for the effect of escitalopram on asthma will be explored.

Inclusion criteria

• Moderate to severe persistent asthma
• Treatment with medium to high dose ICS and LABA therapy
• Three or more severe asthma exacerbations (requiring ≥ 3 days of systemic corticosteroids) in the past year
• Age 18-75 years old, male or female sex, English or Spanish speaking
• Participants will be required to be clinically stable with no recent exacerbations, infections or changes in asthma controller therapy for at least 4 weeks before study entry
• Biologic therapy for asthma (e.g., omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) will be allowed if started at least 6 months prior to randomization

Exclusion criteria

• Current substance use disorder and/or current tobacco use or greater than 10 pack-years lifetime use
• A current MDD episode as well as bipolar disorder, schizophrenia, or schizoaffective disorder
• Vulnerable populations including intellectual disability or other severe cognitive impairment, inmates, pregnant or nursing women or women of childbearing age who will not use UT Southwestern IRB-approved methods of birth control or abstinence during the study
• Currently taking an antidepressant (antidepressants that are not SSRIs nor SNRIs prescribed for an indication other than depression at subtherapeutic doses are acceptable)
• High risk for suicide defined as > 1 past suicide attempts or any attempt within the past 12 months
• Severe or life-threatening medical illness that would make completion of study unlikely or clinically significant laboratory or ECG findings at baseline