Escitalopram in Asthma Patients With Frequent Exacerbation

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
UT Southwestern, 1440 Empire Central, Ste. LD4.100
RECRUITING
Dallas
Contact Information
Primary
Reagan Volzer, M.S.
reagan.volzer@utsouthwestern.edu
214-645-6963
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 105
Treatments
Placebo_comparator: Placebo
Participants will receive an inactive placebo by mouth using the same administration schedule as for escitalopram.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov