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Selective Serotonin Reuptake Inhibitor

Escitalopram for Asthma

Phase 2
Waitlist Available
Led By Sherwood Brown, M.D, Ph.D, MBA
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderate to severe persistent asthma
Treatment with medium to high dose ICS and LABA therapy
Must not have
Current substance use disorder and/or current tobacco use or greater than 10 pack-years lifetime use
Severe or life-threatening medical illness that would make completion of study unlikely or clinically significant laboratory or ECG findings at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks

Summary

This trial will assess the effects of a medication called escitalopram, which is commonly used to treat mood and anxiety disorders, on asthma. Previous studies have shown that this medication may help reduce asthma

Who is the study for?
This trial is for asthma patients aged 18-65 who've had three or more severe exacerbations in the past year, despite being on medium to high dose inhalers and long-acting bronchodilators. They must be stable with no recent flare-ups or therapy changes for four weeks before joining. Those on biologic therapies can join if started six months prior.
What is being tested?
The study tests whether escitalopram, an antidepressant, reduces asthma attacks compared to a placebo. Participants will receive either escitalopram or a placebo and their number of asthma exacerbations will be tracked as the main outcome.
What are the potential side effects?
Escitalopram may cause side effects like nausea, sleep issues, fatigue, dry mouth, increased sweating, and sexual dysfunction. It's important to note that not everyone experiences these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate to severe asthma that doesn't go away.
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I am on a medium to high dose of inhaled corticosteroids and long-acting beta agonists.
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I've had 3 or more severe asthma attacks needing steroids for 3+ days in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently use substances or tobacco, or have a history of heavy tobacco use.
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I do not have a severe illness or abnormal lab/ECG results that could stop me from completing the study.
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I have a mental health condition, but it is not bipolar, schizophrenia, or schizoaffective disorder.
Select...
I am currently on antidepressant medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total number of exacerbations
Secondary study objectives
At least one exacerbation
Time to first exacerbation

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: EscitalopramActive Control1 Intervention
Participants will take oral escitalopram 10 mg per day for two weeks, followed by oral escitalopram 20 mg per day for 22 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive an inactive placebo by mouth using the same administration schedule as for escitalopram.

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,922 Previous Clinical Trials
47,760,633 Total Patients Enrolled
282 Trials studying Asthma
114,523 Patients Enrolled for Asthma
University of Texas Southwestern Medical CenterLead Sponsor
1,079 Previous Clinical Trials
1,056,059 Total Patients Enrolled
9 Trials studying Asthma
1,037 Patients Enrolled for Asthma
Sherwood Brown, M.D, Ph.D, MBAPrincipal InvestigatorUTSW Medical Center
~70 spots leftby Dec 2028
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