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Escitalopram in Asthma Patients With Frequent Exacerbation

NCT06216535 · University of Texas Southwestern Medical Center
In plain English

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About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 105 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-05-19
Estimated completion: 2029-06-01
Last updated: 2026-01-26
Interventions
Drug: EscitalopramDrug: Placebo
Primary outcomes
  • Total number of severe asthma exacerbations (24 weeks)
Sponsor
University of Texas Southwestern Medical Center · other
With: National Heart, Lung, and Blood Institute (NHLBI)
Contacts & investigators
ContactReagan Volzer, M.S. · contact · reagan.volzer@utsouthwestern.edu · 214-645-6963
InvestigatorSherwood Brown, M.D, Ph.D, MBA · principal_investigator, UTSW Medical Center
All locations (1)
UT Southwestern, 1440 Empire Central, Ste. LD4.100Recruiting
Dallas, Texas, United States