Escitalopram for Asthma

Recruiting in Palo Alto (17 mi)

Overseen by Sherwood Brown, M.D, Ph.D, MBA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sherwood Brown, M.D, Ph.D, MBA

Principal Investigator

UTSW Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 65 years old and speak English or Spanish.

I have been on asthma biologic therapy for at least 6 months.

I have moderate to severe asthma that doesn't go away.

Exclusion Criteria

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

I currently use substances or tobacco, or have a history of heavy tobacco use.

I do not have a severe illness or abnormal lab/ECG results that could stop me from completing the study.

Treatment Details

Interventions

• Escitalopram (Selective Serotonin Reuptake Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Escitalopram Active Control 1 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: Placebo Placebo Group 1 Intervention

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

Escitalopram is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Lexapro for:

• Major depressive disorder
• Generalized anxiety disorder

🇪🇺 Approved in European Union as Cipralex for:

• Major depressive episodes
• Generalized anxiety disorder
• Social anxiety disorder
• Panic disorder with or without agoraphobia
• Obsessive-compulsive disorder

🇨🇦 Approved in Canada as Cipralex for:

• Major depressive disorder
• Generalized anxiety disorder
• Social anxiety disorder

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

1440 Empire Central, Ste. LD4.100 Dallas, TX

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1102

Patients Recruited

1,077,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Patients Recruited

47,860,000+