NCT06216535

Escitalopram in Asthma Patients With Frequent Exacerbation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Escitalopram	Escitalopram is an FDA-approved SSRI antidepressant that is administered by mouth
DRUG	Placebo	Inactive placebo comparator

Timeline

• Start date: 2025-05-19
• Primary completion: 2028-12-01
• Completion: 2029-06-01
• First posted: 2024-01-22
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study