Recruiting PHASE2 Asthma

New treatment option for Asthma

Official title Escitalopram in Asthma Patients With Frequent Exacerbation

ClinicalTrials.gov ID: NCT06216535

What this study is testing

What is Escitalopram?

Escitalopram is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for asthma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 2: a mid-size study of how well it works
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • 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...

You likely can't join if

  • 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...
  • Currently taking an antidepressant (antidepressants that are not SSRIs nor SNRIs prescribed for an indication other than depression at subtherapeutic...
  • 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...
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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...
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Dallas, Texas, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.