Escitalopram for adults with asthma and frequent exacerbations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• HB0056 in adults with moderate to severe asthma

  This study tests HB0056 versus a placebo to see if it helps adults with moderate to severe asthma reduce rescue inhaler use and improve symptoms.

  Recruiting at 2 sites Phase 1/2 Shanghai Huaota Biopharmaceutical Co., Ltd. · Beijing and 1 other locations · NCT07899996

• Tilrekimig (PF-07275315) for Severe Asthma: Aimed at Adults with Frequent Exacerbations

  This study tests whether tilrekimig helps people with severe asthma who have had multiple flare-ups in the past year, by comparing it to a placebo given every four weeks.

  Recruiting at 4 sites Phase 3 Pfizer · River Forest, Illinois and 11 other locations · NCT07869043

• Inhaled CHF10136 safety and pharmacokinetics in healthy adults and adults with asthma

  This first-in-human study tests inhaled CHF10136 to see if it is safe and well tolerated, how it behaves in the body, and how it affects adults with asthma compared with placebo.

  Recruiting Phase 1 Chiesi Farmaceutici S.p.A. · Leeds and 2 other locations · NCT07851623

• Biologics for Type 2 Inflammation in Asthma and COPD in Real World

  This real-world study tests whether six biologic drugs can reduce flare-ups and improve symptoms in adults with asthma or COPD treated in routine care in China.

  Recruiting Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07823842

• GSK5784283 vs placebo in uncontrolled asthma (PERSIST ASTHMA-2)

  A new medicine called GSK5784283 is being tested to see if it lowers asthma flare-ups better than a placebo in people with uncontrolled asthma.

  Recruiting at 7 sites Phase 3 GlaxoSmithKline · San Diego, California and 6 other locations · NCT07782996

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.