Escitalopram in Asthma Patients With Frequent Exacerbation

NCT06216535 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STU-2023-0494R61HL167909-01A1
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Escitalopram; SSRI; Adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Asthma Control Questionnaire (ACQ)

  24 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive an inactive placebo by mouth using the same administration schedule as for escitalopram.

Drug: Placebo

Escitalopram

ACTIVE COMPARATOR

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

Interventions

Escitalopram DRUG

Escitalopram is an FDA-approved SSRI antidepressant that is administered by mouth

Escitalopram

Placebo DRUG

Inactive placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UT Southwestern, 1440 Empire Central, Ste. LD4.100

Dallas, Texas, 75247, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sherwood Brown, M.D, Ph.D, MBA

  UTSW Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reagan Volzer, M.S.

CONTACT

214-645-6963; reagan.volzer@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A randomization list will be maintained in a password-protected folder by an unblinded staff member with no participant contact and by the investigational pharmacy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a two-arm, 26-week, randomized, single-center, double-blind, parallel group trial designed to evaluate the efficacy of treatment with escitalopram vs. placebo to reduce asthma exacerbations in n = 105 participants, ages 18-75 years, with moderate-to-severe asthma.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: May 19, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)