Escitalopram for Asthma

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

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.

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.

What data supports the effectiveness of the drug Escitalopram for asthma?

There is minimal data on using Escitalopram specifically for asthma, but it has shown effectiveness in treating depression, which is common in asthma patients. In a study, Escitalopram led to greater depression remission and reduced oral corticosteroid use in asthma patients. ^{1 2 3 4 5}

Is Escitalopram safe for use in humans?

Escitalopram, also known as Lexapro, is generally considered safe for use in adults with depression, with common side effects like nausea and dry mouth being mild and temporary. However, in studies involving asthma patients, adverse events were slightly more common among those taking the medication, though specific details were not well-reported. ^{1 6 7 8 9}

How does the drug escitalopram differ from other treatments for asthma?

Escitalopram is unique for asthma treatment because it is primarily a selective serotonin reuptake inhibitor (SSRI) used for depression and anxiety, not typically for asthma. Its potential use in asthma is novel, as it may work differently by affecting serotonin levels, unlike standard asthma treatments that focus on reducing inflammation or opening airways. ^{7 10 11 12 13}

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.

Timeline

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

Treatment Details

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.

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

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for the treatment of psychological distress in patients with asthma: a systematic review and meta-analysis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Escitalopram for severe asthma and major depressive disorder: a randomized, double-blind, placebo-controlled proof-of-concept study. [2013]

3. India pubmed.ncbi.nlm.nih.gov

Efficacy of escitalopram in patients with severe depression: a pooled analysis. [2013]

4. India pubmed.ncbi.nlm.nih.gov

Escitalopram Versus Citalopram and Sertraline: A Double-Blind Controlled, Multi-centric Trial in Indian Patients with Unipolar Major Depression. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of escitalopram versus citalopram for the treatment of major depressive disorder in a geriatric population. [2022]

6. India 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Panic attacks associated with citalopram. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Overview of the safety of citalopram. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Citalopram as treatment of depression in patients with epilepsy. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Escitalopram (Lexapro) for depression. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Escitalopram: a pharmacoeconomic review of its use in depression. [2018]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Escitalopram: a review of its use in the management of anxiety disorders. [2019]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Escitalopram: a review of its use in the management of major depressive disorder in adults. [2022]