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Selective Serotonin Reuptake Inhibitor

Escitalopram for Asthma

Phase 2

Waitlist Available

Led By Sherwood Brown, M.D, Ph.D

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total number of exacerbations

Secondary outcome measures

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,694 Total Patients Enrolled

9 Trials studying Asthma

1,037 Patients Enrolled for Asthma

Sherwood Brown, M.D, Ph.DPrincipal InvestigatorUTSW Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for individuals seeking to participate in this clinical study?

"To be eligible for enrollment in this research study, prospective participants must have a diagnosis of asthma and fall between the ages of 18 and 65. The trial aims to recruit approximately 105 individuals with these criteria."

Answered by AI

Is the age criterion for eligibility in this study limited to individuals below 85 years old?

"This clinical trial specifically seeks individuals between the ages of 18 and 65 who meet the eligibility criteria. For patients younger than 18, there are a total of 123 trials available, while for those over the age of 65, there are a total of 197 trials accessible."

Answered by AI

Has Escitalopram received official endorsement from the FDA?

"Based on our assessment, the safety of Escitalopram in this Phase 2 trial is rated at 2. While there is some evidence supporting its safety, no data has been provided to support its efficacy yet."

Answered by AI

Are participants currently being recruited for this research study?

"According to the provided information from clinicaltrials.gov, this specific clinical trial is no longer actively recruiting participants. It was initially posted on March 1st, 2024 and last updated on January 11th, 2024. However, it's worth noting that there are currently 307 other ongoing clinical trials actively seeking patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Escitalopram in Asthma Patients With Frequent Exacerbation

Sherwood Brown, MD, PhD 2024. "Escitalopram in Asthma Patients With Frequent Exacerbation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06216535.