Escitalopram in Asthma Patients With Frequent Exacerbation

Asthma Clinical Trial

Official title:

Escitalopram in Asthma Patients With Frequent Exacerbation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06216535
• Other study ID #: STU-2023-0494
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: June 1, 2029

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Alejandro Cabrera-Aguirre, MBBS
• Phone: 214-645-6953
• Email: alejandro.cabreraaguirre[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A 24-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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: June 1, 2029
• Est. primary completion date: December 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 18-65 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) 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

• Psychiatric illnesses other than MDD or anxiety disorders, including bipolar disorder, schizophrenia, 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

• 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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Escitalopram
Escitalopram is an FDA-approved SSRI antidepressant that is administered by mouth
• Placebo
Inactive placebo comparator

Locations

Country	Name	City	State
United States	1440 Empire Central, Ste. LD4.100	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of exacerbations	Severe asthma exacerbations will be defined by use of oral corticosteroids for = 3 days consistent with criteria from the Severe Asthma Research Program (SARP).	24 weeks
Secondary	At least one exacerbation	Severe asthma exacerbations will be defined by use of oral corticosteroids for = 3 days consistent with criteria from the Severe Asthma Research Program (SARP).	24 weeks
Secondary	Time to first exacerbation	Severe asthma exacerbations will be defined by use of oral corticosteroids for = 3 days consistent with criteria from the Severe Asthma Research Program (SARP).	24 weeks