Escitalopram for Asthma

Recruiting at 1 trial location

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

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Texas Southwestern Medical Center

Must be taking: ICS, LABA

Must not be taking: Antidepressants

Disqualifiers: Substance use, Tobacco use, Bipolar, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether escitalopram, a common antidepressant, can reduce severe asthma attacks. Researchers aim to determine if it improves asthma control compared to a placebo (a pill with no active medicine). Suitable candidates for this trial include individuals with moderate to severe persistent asthma, who are already on certain asthma medications, and have experienced three or more serious asthma flare-ups in the past year. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking an antidepressant.

Is there any evidence suggesting that escitalopram is likely to be safe for humans?

Research has shown that escitalopram, a common antidepressant, is generally well-tolerated. Studies have found that it not only improves mood in people with depression but also helps reduce asthma attacks. Specifically, patients taking escitalopram experienced fewer asthma flare-ups and better asthma control.

Although these specific studies did not focus on side effects, escitalopram is already widely used to treat depression and anxiety, so doctors are familiar with its safety. Common side effects might include nausea, trouble sleeping, or headaches, but serious problems are rare. The trial is in the middle phase, indicating that enough safety information exists for escitalopram to be considered safe for further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Unlike standard asthma treatments, which typically include inhaled corticosteroids and bronchodilators, escitalopram is unique because it is traditionally an antidepressant. Researchers are excited about escitalopram for asthma because it targets the nervous system, which may play a role in asthma symptoms by influencing stress and inflammation pathways. This could offer a new way to manage asthma, especially for patients whose symptoms are exacerbated by stress. Additionally, escitalopram is taken orally, which might be more convenient for some patients compared to inhalers.

What evidence suggests that escitalopram might be an effective treatment for asthma?

Research has shown that escitalopram, a medication for depression, might also benefit people with asthma. In this trial, participants will receive either escitalopram or a placebo. Studies have found that patients taking escitalopram experienced fewer asthma attacks, requiring less additional treatment to manage their asthma. Additionally, escitalopram reduced feelings of depression in these patients. While escitalopram is known for treating mood disorders, it may also aid in asthma control. ^{1 2 3 6 7}

Who Is on the Research Team?

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

Principal Investigator

UTSW Medical Center

Are You a Good Fit for This Trial?

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

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

I am on a medium to high dose of inhaled corticosteroids and long-acting beta agonists.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral escitalopram or placebo for 24 weeks

24 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Escitalopram

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Escitalopram, the active s-enantiomer of citalopram, is an effective selective serotonin reuptake inhibitor (SSRI) used to treat major depressive disorder.

As an SSRI, escitalopram works by increasing serotonin levels in the brain, which can help improve mood and alleviate symptoms of depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram (Lexapro) for depression. Masilamani, S., Ruppelt, SC.[2022]

Escitalopram is an effective and well-tolerated treatment for various anxiety disorders and OCD, showing at least equal efficacy to paroxetine and a quicker response in panic disorder.

It has a favorable safety profile with fewer discontinuation symptoms compared to paroxetine, and its pharmacokinetics allow for convenient once-daily dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Escitalopram: a review of its use in the management of anxiety disorders. Dhillon, S., Scott, LJ., Plosker, GL.[2019]

In a pooled analysis of three clinical trials involving 506 severely depressed patients, escitalopram was found to be significantly more effective than citalopram, with a greater mean change in depression scores (p = 0.003).

The response rate for escitalopram was also higher at 56% compared to 41% for citalopram (p = 0.007), confirming its superior efficacy in treating severe depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of escitalopram in patients with severe depression: a pooled analysis. Llorca, PM., Azorin, JM., Despiegel, N., et al.[2013]

In a study of 691 geriatric patients, those treated with escitalopram showed better treatment persistence and were less likely to switch medications compared to those on citalopram, indicating escitalopram may be a more reliable option for older adults with major depressive disorder.

Patients on escitalopram experienced significantly fewer hospitalizations and lower total healthcare costs, primarily due to reduced hospitalization rates, suggesting that escitalopram not only helps manage depression effectively but also reduces overall healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of escitalopram versus citalopram for the treatment of major depressive disorder in a geriatric population. Wu, E., Greenberg, PE., Yang, E., et al.[2022]

A study evaluated the adherence to prescribing guidelines for citalopram and found that implementing an EMIS safety prompt and providing prescriber training led to a significant reduction in incorrect prescriptions for patients over 65, from 8 to 1.

The interventions also decreased dangerous drug interactions involving citalopram from 44 to 8 and overall unsafe prescribing from 47 to 9, highlighting improved patient safety and resource use that could be applied to other medications with safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safer citalopram use in primary care: Can staff education and prescribing prompts improve adherence to national guidance? A closed loop clinical audit, service evaluation and quality improvement study. Waller, M.[2023]

Citalopram, a selective serotonin reuptake inhibitor (SSRI), is considered safe for treating depression in adults, including the elderly and those with mild to moderate kidney and liver issues, based on data from clinical trials and published studies.

Common side effects like nausea and dry mouth are mostly mild and transient, and citalopram does not significantly increase the risk of serious issues such as suicide or heart problems, making it comparable in safety to other SSRIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the safety of citalopram. Nemeroff, CB.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37952772/

The efficacy of citalopram or escitalopram in patients with ... Objective: To explore the relationship between antidepressant use, depressive symptoms, and asthma control, pooled data from 3 randomized trials ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1081120623014011

The efficacy of citalopram or escitalopram in patients with ... Conclusion. Citalopram or escitalopram exhibited efficacy in reducing depressive symptoms and the need for rescue oral corticosteroids in patients with asthma ...

3. pulmonologyadvisor.com pulmonologyadvisor.com/news/citalopram-and-escitalopram-effective-for-asthma-and-depression/

Citalopram and Escitalopram Effective for Patients With ... Patients with increased asthma exacerbations and major depressive disorder achieved improved asthma control using citalopram and ...

4. annallergy.org annallergy.org/article/S1081-1206(23)01401-1/abstract

The efficacy of citalopram or escitalopram in patients with ... Citalopram or escitalopram exhibited efficacy in reducing depressive symptoms and the need for rescue oral corticosteroids in patients with asthma and major ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6107441/

A Randomized, Double-Blind, Placebo-Controlled Trial of ... Our hypothesis was that escitalopram therapy would decrease depressive symptom severity, improve asthma control and decrease the need for rescue ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/453418

Escitalopram in Asthma Patients With Frequent Exacerbation Clinical studies of SSRIs in depressed people with asthma were associated with decreased asthma exacerbations and improvement in asthma control.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06216535

Escitalopram in Asthma Patients With Frequent Exacerbation Clinical studies of SSRIs in depressed people with asthma were associated with decreased asthma exacerbations and improvement in asthma control. In this study, ...