Escitalopram in Asthma Patients With Frequent Exacerbation

Plain English Summary

Escitalopram in Asthma Patients With Frequent Exacerbation is a Phase 2 clinical trial sponsored by University of Texas Southwestern Medical Center studying Asthma. This study is testing if the antidepressant escitalopram can help people with frequent, severe asthma attacks. It is for adults aged 18-75 with moderate to severe asthma who have had at least three severe attacks in the past year. Participants will take either escitalopram or a placebo (inactive pill) for 24 weeks and have their asthma attacks monitored. Standard asthma treatments are the current alternative for managing frequent exacerbations. The trial aims to enroll 105 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18-75 years old, have moderate to severe asthma, and have had 3 or more severe asthma attacks in the last year requiring steroid treatment. You must be stable on your current asthma medications for at least 4 weeks before starting the study. You cannot join if you have a current major depression episode, bipolar disorder, schizophrenia, or a history of suicide attempts in the last year. Current tobacco users or those with a history of substance use disorder are also excluded. This trial is studying Asthma, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to count how many severe asthma attacks requiring steroid treatment occur over 24 weeks, showing if escitalopram reduces these serious events. The specific primary outcome measures are: Total number of severe asthma exacerbations (24 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial aims to fill a treatment gap by exploring if a common antidepressant can reduce severe asthma attacks, a significant problem for many patients. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Asthma, where improved treatment options are needed.

Investor Insight

This trial explores a novel use for a well-established drug, potentially expanding its market and offering a new treatment option for a large patient population with uncontrolled asthma. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this trial is right for you, especially about how escitalopram might interact with your current asthma and other medications. You will need to take study medication daily and attend regular clinic visits for check-ups and asthma assessments over 24 weeks. Your asthma attacks and medication use will be carefully tracked throughout the study. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 105 participants

Interventions

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

Primary Outcomes

• Total number of severe asthma exacerbations (24 weeks)

Secondary Outcomes

• Asthma Control Questionnaire (ACQ) (24 weeks)

Full Eligibility Criteria

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 18-75 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

Exclusion Criteria:

* 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

Trial Locations

• UT Southwestern, 1440 Empire Central, Ste. LD4.100, Dallas, Texas, United States

Frequently Asked Questions

Related Conditions

• Asthma
• Allergic Rhinitis
• Eczema
• Anxiety Disorders
• Depression
• Mood Disorders
• Respiratory Tract Infections
• Chronic Obstructive Pulmonary Disease (COPD)
• Bronchitis
• Pneumonia

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