Escitalopram for adults with asthma and frequent exacerbations
Escitalopram in Asthma Patients With Frequent Exacerbation
This trial will test whether the antidepressant escitalopram can reduce asthma flare-ups in adults with moderate-to-severe asthma who continue to have frequent exacerbations despite inhaled steroid and long-acting bronchodilator therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06216535 on ClinicalTrials.gov |
What this trial studies
This is a 26-week, randomized, double-blind, placebo-controlled Phase 2 trial enrolling 105 adults with moderate-to-severe persistent asthma and at least three exacerbations in the prior year. Participants will be randomly assigned to escitalopram or matched placebo in addition to their usual inhaled corticosteroid and long-acting beta-agonist therapy. The primary outcome is the number of times systemic corticosteroids are required for asthma exacerbations, with the Asthma Control Questionnaire as a key secondary outcome; mood, anxiety, and psychological triggers will also be measured. Blood biomarkers (IL-6, peripheral eosinophils) and fractional exhaled nitric oxide (FeNO) will be collected to explore immune and inflammatory mechanisms related to any clinical effects.
Who should consider this trial
Good fit: Adults aged 18–75 with moderate-to-severe persistent asthma on medium-to-high dose inhaled corticosteroid plus LABA who have had three or more exacerbations in the past year, are clinically stable for ≥4 weeks, and speak English or Spanish would be ideal candidates.
Not a fit: Patients with a current major depressive episode, bipolar disorder, schizophrenia, active substance use disorder, significant tobacco use (>10 pack-years or current smoker), pregnancy or nursing, or other excluded conditions are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, escitalopram could lower the frequency of severe asthma exacerbations and improve overall asthma control for patients with frequent flares.
How similar studies have performed: Prior clinical studies of SSRIs in depressed people with asthma reported fewer exacerbations and better control, but the approach has been less tested in non-depressed patients with frequent exacerbations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- UT Southwestern, 1440 Empire Central, Ste. LD4.100 — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sherwood Brown, M.D, Ph.D, MBA — UTSW Medical Center
- Study coordinator: Reagan Volzer, M.S.
- Email: reagan.volzer@utsouthwestern.edu
- Phone: 214-645-6963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.