Escitalopram in Asthma Patients With Frequent Exacerbation

Antidepressants, particularly selective serotonin reuptake inhibitors (SSRIs), such as escitalopram are widely used for mood and anxiety disorders. However, they have also been explored, with promising findings, for a variety of disorders outside of psychiatry. Clinical studies of SSRIs in depressed people with asthma were associated with decreased asthma exacerbations and improvement in asthma control. In this study, the number of asthma exacerbations will be assessed as the primary outcome measure in patients using escitalopram vs. placebo.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Escitalopram

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Reagan Volzer, M.S.; Phone Number: 214-645-6963; Email: reagan.volzer@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Recruiting
      • UT Southwestern, 1440 Empire Central, Ste. LD4.100
      • Principal Investigator: Sherwood Brown, M.D, Ph.D
      • Contact: Reagan Volzer, MS; Phone Number: 214-645-6963; Email: Reagan.Volzer@UTSouthwestern.edu
      • Contact: Génesis González Álvarez, MS; Phone Number: 214-645-6967; Email: Genesis.GonzalezAlvarez@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive an inactive placebo by mouth using the same administration schedule as for escitalopram.	Drug: Placebo; Inactive placebo comparator
Active Comparator: Escitalopram; Participants will take oral escitalopram 10 mg per day for two weeks, followed by oral escitalopram 20 mg per day for 22 weeks. Participants will take oral escitalopram 10 mg per day for one week at the final study visit.	Drug: Escitalopram; Escitalopram is an FDA-approved SSRI antidepressant that is administered by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of severe asthma exacerbations	A count outcome variable capturing the total number of severe asthma exacerbations. Severe asthma exacerbations will be defined by the use of oral corticosteroids ≥ 3 days, or hospitalization or emergency department visit leading to treatment with systemic glucocorticoids	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Questionnaire (ACQ)	The ACQ is a 7-item, self-report tool that measures asthma symptomatology over time. The ACQ assesses symptoms pertinent to the primary clinical goal of asthma management as identified by international guidelines including (a) day and nighttime symptoms, (b) activity limitation, (c) use of prn bronchodilators, and (d) FEV1% predicted.	24 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Sherwood Brown, M.D, Ph.D, MBA, UTSW Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Adults; Escitalopram; SSRI
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amines; Nitriles; Propylamines; Benzofurans; Escitalopram
• Other Study ID Numbers: STU-2023-0494; R61HL167909-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No