AsthmaPhase 2NCT06216535
Escitalopram in Asthma Patients With Frequent Exacerbation
A Phase 2 study testing Escitalopram in people with Asthma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2025to 1 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe persistent asthma
- Treatment with medium to high dose ICS and LABA therapy
- Three or more severe asthma exacerbations (requiring ≥ 3 days of systemic corticosteroids) in the past year
- Age 18-75 years old, male or female sex, English or Spanish speaking
- Participants will be required to be clinically stable with no recent exacerbations, infections or changes in asthma controller therapy for at least 4 weeks before study entry
- Biologic therapy for asthma (e.g., omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) will be allowed if started at least 6 months prior to randomization
Who cannot join
- Current substance use disorder and/or current tobacco use or greater than 10 pack-years lifetime use
- A current MDD episode as well as bipolar disorder, schizophrenia, or schizoaffective disorder
- 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
- Currently taking an antidepressant (antidepressants that are not SSRIs nor SNRIs prescribed for an indication other than depression at subtherapeutic doses are acceptable)
- High risk for suicide defined as > 1 past suicide attempts or any attempt within the past 12 months
- Severe or life-threatening medical illness that would make completion of study unlikely or clinically significant laboratory or ECG findings at baseline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern, 1440 Empire Central, Ste. LD4.100
Dallas, Texas, 75247
Reagan Volzer, MS, 214-645-6963, Reagan.Volzer@UTSouthwestern.edu
Génesis González Álvarez, MS, 214-645-6967, Genesis.GonzalezAlvarez@UTSouthwestern.edu
About this study
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.
Read the detailed description
A 26-week, randomized, double-blind, placebo-controlled trial of escitalopram will be conducted in 105 people with moderate to severe persistent asthma who, despite treatment with medium to high dose inhaled corticosteroids and long-acting beta-agonist therapy, had ≥ 3 asthma exacerbations in the past year. The primary outcome measure will be the number of times systemic corticosteroids are given for an asthma exacerbation with the Asthma Control Questionnaire as a secondary outcome measure. Mood and anxiety symptoms and functioning will be assessed as will the role of psychological asthma triggers on asthma symptom exacerbation. Serum IL-6 and peripheral eosinophil levels as well as fractional exhaled nitric oxide (FeNO) will be assessed. Thus, psychological/psychiatric and biological or immune mechanisms for the effect of escitalopram on asthma will be explored.
- Conditions
- Asthma
- Being tested
- Escitalopram, Placebo
- Keywords
- Escitalopram, SSRI, Adults
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Escitalopram is an FDA-approved SSRI antidepressant that is administered by mouth
PlaceboDrug
Inactive placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive an inactive placebo by mouth using the same administration schedule as for escitalopram. Receives: Drug: Placebo |
| Escitalopram | Active comparator | Participants will take oral escitalopram 10 mg per day for two weeks, followed by oral escitalopram 20 mg per day for 22 weeks. Participants will take oral escitalopram 10 mg per day for one week at the final study visit. Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of severe asthma exacerbations
A count outcome variable capturing the total number of severe asthma exacerbations. Severe asthma exacerbations will be defined by the use of oral corticosteroids ≥ 3 days, or hospitalization or emergency department visit leading to treatment with systemic glucocorticoids
Measured: 24 weeks
Secondary outcomes (1)
Asthma Control Questionnaire (ACQ)
The ACQ is a 7-item, self-report tool that measures asthma symptomatology over time. The ACQ assesses symptoms pertinent to the primary clinical goal of asthma management as identified by international guidelines including (a) day and nighttime symptoms, (b) activity limitation, (c) use of prn bronchodilators, and (d) FEV1% predicted.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start19 May 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a two-arm, 26-week, randomized, single-center, double-blind, parallel group trial designed to evaluate the efficacy of treatment with escitalopram vs. placebo to reduce asthma exacerbations in n = 105 participants, ages 18-75 years, with moderate-to-severe asthma.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sherwood Brown, MD, PhD, University of Texas Southwestern Medical Center
- Investigators
- Sherwood Brown, M.D, Ph.D, MBA, Principal investigator, UTSW Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216535
- Sponsor's protocol ID
- STU-2023-0494
- Other IDs
- R61HL167909-01A1
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escitalopram in Asthma Patients With Frequent Exacerbation
- ClinicalTrials.gov ID
- NCT06216535
- Acronym / sponsor ID
- STU-2023-0494
- Conditions
- Asthma
- Keywords
- Escitalopram, SSRI, Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 May 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A 26-week, randomized, double-blind, placebo-controlled trial of escitalopram will be conducted in 105 people with moderate to severe persistent asthma who, despite treatment with medium to high dose inhaled corticosteroids and long-acting beta-agonist therapy, had ≥ 3 asthma exacerbations in the past year. The primary outcome measure will be the number of times systemic corticosteroids are given for an asthma exacerbation with the Asthma Control Questionnaire as a secondary outcome measure. Mood and anxiety symptoms and functioning will be assessed as will the role of psychological asthma triggers on asthma symptom exacerbation. Serum IL-6 and peripheral eosinophil levels as well as fractional exhaled nitric oxide (FeNO) will be assessed. Thus, psychological/psychiatric and biological or immune mechanisms for the effect of escitalopram on asthma will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a two-arm, 26-week, randomized, single-center, double-blind, parallel group trial designed to evaluate the efficacy of treatment with escitalopram vs. placebo to reduce asthma exacerbations in n = 105 participants, ages 18-75 years, with moderate-to-severe asthma.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive an inactive placebo by mouth using the same administration schedule as for escitalopram. |
| Escitalopram | Active comparator | Drug: EscitalopramParticipants will take oral escitalopram 10 mg per day for two weeks, followed by oral escitalopram 20 mg per day for 22 weeks. Participants will take oral escitalopram 10 mg per day for one week at the final study visit. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Moderate to severe persistent asthma
- Treatment with medium to high dose ICS and LABA therapy
- Three or more severe asthma exacerbations (requiring ≥ 3 days of systemic corticosteroids) in the past year
- Age 18-75 years old, male or female sex, English or Spanish speaking
- Participants will be required to be clinically stable with no recent exacerbations, infections or changes in asthma controller therapy for at least 4 weeks before study entry
Key exclusion criteria (6 listed)
- Current substance use disorder and/or current tobacco use or greater than 10 pack-years lifetime use
- A current MDD episode as well as bipolar disorder, schizophrenia, or schizoaffective disorder
- 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
- Currently taking an antidepressant (antidepressants that are not SSRIs nor SNRIs prescribed for an indication other than depression at subtherapeutic doses are acceptable)
- High risk for suicide defined as > 1 past suicide attempts or any attempt within the past 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramEscitalopram is an FDA-approved SSRI antidepressant that is administered by mouth | Drug | Escitalopram |
| PlaceboInactive placebo comparator | Drug | Placebo |
Primary outcome
Total number of severe asthma exacerbations
Time frame: 24 weeks
A count outcome variable capturing the total number of severe asthma exacerbations. Severe asthma exacerbations will be defined by the use of oral corticosteroids ≥ 3 days, or hospitalization or emergency department visit leading to treatment with systemic glucocorticoids
1 secondary outcome
Asthma Control Questionnaire (ACQ)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sherwood Brown, M.D, Ph.D, MBA principal investigator
UTSW Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Escitalopram in people with Asthma, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reagan Volzer, M.S. (214-645-6963, reagan.volzer@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of severe asthma exacerbations (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.