Escitalopram in Asthma Patients with Frequent Exacerbation

The University of Texas System (UT)

Status and phase: Not yet enrolling; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Escitalopram

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06216535

R61HL167909-01A1 (U.S. NIH Grant/Contract)

STU-2023-0494

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Escitalopram

Active Comparator group

Description:

Participants will take oral escitalopram 10 mg per day for two weeks, followed by oral escitalopram 20 mg per day for 22 weeks.

Treatment:

Drug: Escitalopram