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Asthma AttackNCT07396987

Boosting Referrals to Asthma Specialists for Patients Seen at the Emergency Room for an Asthma Exacerbation

A study testing ER-Initiated Telehealth Referral in people with Asthma Attack and Asthma Control, run by Juan Carlos Cardet at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is testing a new way to help adults with asthma get follow up care after an emergency room (ER) visit for an asthma attack. Many people who come to the ER for asthma never see an asthma specialist afterward, even though specialists can offer treatments such as advanced inhalers or biologic medicines that… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ER-Initiated Telehealth Referral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
19 Jul 2026to Aug 2027
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Asthma diagnosis ≥1 year
  • Seen in ER for asthma exacerbation
  • Persistent asthma on controller therapy
  • ≥1 asthma exacerbation in prior year

Who cannot join

  • Patients who have seen an asthma specialist (allergist or pulmonologist) for asthma in the past 1 year
  • Diagnosis of other pulmonary diseases (e.g., COPD, interstitial lung disease, etc.)
  • We will allow for current smokers, vapers and cannabis users as long as they meet one of the COPD-allowable pathways below.
  • COPD-allowable pathways:
  • If none of the below are satisfied, then exclude for COPD.
  • Documentation: PFTs must be within 36 months of enrollment date; smoking history must be calculated and entered in this form based on patient input. Pack- year history will be collected for characterization/analysis but will not determineeligibility.
Show all 10Show fewer
  • We will allow for COPD as long as they are:
  • never smokers/vapers/cannabis users;
  • former or current smokers/vapers/cannabis users with normal PFTs with FEV1/FVC >=70% documented in a medical record within 36 months of the enrollment date
  • former or current smoker/vapers/cannabis users with obstruction noted on PFTs (i.e., FEV1/FVC <70%) but who demonstrates BOTH acute bronchodilator reversibility (i.e., >10% increase in either FEV1%predicted or FVC% predicted) AND have a normal diffusing capacity (DLCO)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Amanda McNamara, BA, LPN contact

813-396-2729

Alett1@usf.edu

United States1 site, 1 recruiting

  • Tampa General Hospital Emergency Room

    Tampa, Florida, 33606

    Hope Brunner, RN, BSN, 813-844-7289, hbrunner@tgh.org

    Recruiting

Other trials in United States

About this study

This study is testing a new way to help adults with asthma get follow up care after an emergency room (ER) visit for an asthma attack. Many people who come to the ER for asthma never see an asthma specialist afterward, even though specialists can offer treatments such as advanced inhalers or biologic medicines that may prevent future attacks.

The study will compare two approaches. One group will receive a telehealth appointment with an asthma specialist that is scheduled for them before they leave the ER. The other group will receive the usual care, which typically includes a standard referral but no scheduled appointment. All participants will be offered a prescription for standard controller medication at discharge.

Read more

The main question the study aims to answer is whether arranging a telehealth visit directly from the ER increases the number of patients who complete a follow up appointment with an asthma specialist within three months. The study will also look at whether this approach improves asthma control, reduces repeat ER visits, and helps patients better understand and use their asthma medications.

This research may help identify a practical way to improve access to asthma specialists and reduce the burden of asthma for patients who frequently rely on emergency care.

Being tested
ER-Initiated Telehealth Referral
Keywords
asthma, asthma exacerbation, asthma control, inhaled corticosteroid, Long-Acting Beta-Agonist, Long-Acting Muscarinic Antagonist, Emergency Room, Asthma Control Test, Medication Adherence Report Scale for Asthma, Asthma Symptom Utility Index, barriers to care, social determinants of health, access to care, telehealth, telemedicine
Medical subject headings
Asthma, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ER-Initiated Telehealth ReferralBehavioural

    Participants assigned to the intervention arm will receive an asthma specialist follow up appointment that is scheduled directly from the emergency department before discharge. Emergency department staff will contact the specialist clinic to arrange a telehealth visit within 1-3 weeks. The telehealth visit will address asthma symptoms, medication use, and follow-up care needs. All participants, including those in the intervention arm, will be offered a prescription for standard inhaled corticosteroid/long-acting beta-agonist controller therapy at discharge. The intervention focuses on improving access to specialist care through proactive scheduling and telehealth delivery.

Study groups in NCT07396987
Study groupRoleWhat they receive
Intervention ArmExperimentalParticipants will receive two components: 1. Emergency Room (ER) staff will directly contact the asthma specialist's scheduling team to arrange a follow-up appointment within 1-3 weeks. 2. The follow-up appointment will be conducted via telehealth (including phone calls) to assess follow-up care and asthma control of all participants. Both Arms: • All participants will be offered a prescription for twice-daily ICS/LABA (fluticasone/salmeterol) controller therapy at ER discharge after signing informed consent. These medications are standard of care for asthma. Asthma-related surveys and study-specific questionnaires, "medication side effects (open-ended)" and "follow-up care questions" will be administered during the ER visit and again at the 3-month follow-up phone call.
Receives: Behavioral: ER-Initiated Telehealth Referral
Usual Care ArmNo interventionParticipants will receive an EMR-based referral to an outpatient allergy clinic, with the option of a telehealth or in-person visit at their discretion. This referral will be offered during the 3-month follow-up phone call to ensure clinical equipoise. Both Arms: • All participants will be offered a prescription for twice-daily ICS/LABA (fluticasone/salmeterol) controller therapy at ER discharge after signing informed consent. These medications are standard of care for asthma. Asthma-related surveys and study-specific questionnaires, "medication side effects (open-ended)" and "follow-up care questions" will be administered during the ER visit and again at the 3-month follow-up phone call.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants Completing an Asthma Specialist Follow-Up Visit Within 3 Months After Emergency Department Discharge

    Completion of an asthma specialist follow-up visit will be assessed using documentation in the electronic health record. A visit will be counted if the record shows that the participant completed a telehealth or in-person appointment with an asthma specialist within 3 months after the emergency department discharge. The outcome will be reported as the proportion of participants in each study arm who completed a qualifying specialist visit during the 3-month follow-up period.

    Measured: Within 3 months after emergency department discharge

Secondary outcomes (6)

  1. Proportion of Participants Experiencing an Additional Asthma Exacerbation Within 3 Months After Emergency Department Discharge

    A secondary asthma exacerbation will be identified using electronic health record documentation of an asthma related emergency department visit, hospitalization, or need for systemic corticosteroids within 3 months after discharge. The outcome will be reported as the proportion of participants experiencing at least one exacerbation.

    Measured: Within 3 months after emergency department discharge

  2. Change in Asthma Control Test (ACT) Score From Baseline to 3 Months

    Asthma control will be assessed using the Asthma Control Test (ACT), a validated 5 item questionnaire with scores ranging from 5 to 25, where higher scores indicate better asthma control. The outcome will be reported as the change in ACT score from baseline to 3 months.

    Measured: Within 3 months after emergency department discharge

  3. Improvement in quality of life via Asthma Symptom Utility Index (ASUI)

    Measure will be taken through the Asthma Symptom Utility Index (ASUI), an 11-item questionnaire, adminstered during the ER visit and at three month follow up. The summary score is continuous, ranging from 0 to 1.

    Measured: Within 3 months after emergency department discharge

  4. Adherence to Controllers (MARS5)

    The MARS5 questionnaire is a 5-item self-report questionnaire assessing adherence to treatments like controllers, scoring from 5 (low) to 25 (high). It measures behaviors such as forgetting, altering, stopping, or skipping doses, with a score of or often indicating high adherence.

    Measured: Within 3 months after emergency department discharge

  5. Repeat ER visits

    Repeat ER visits for asthma

    Measured: Within 3 months after emergency department discharge

  6. Asthma hospitalizations

    Participants who are hospitalized for asthma.

    Measured: Within 3 months after emergency department discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start19 Jul 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

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 N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07396987
Sponsor's protocol ID
ORIGINS
Status last verified
Sep 2026
First submitted
30 Jan 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD

Publications

  • Israel E, Cardet JC, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Yawn BP, Arias Hernandez P, Kruse JM, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Madison S, Coyne-Beasley T, Hammer GM, Kaplan BM, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, McKee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang KL, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A, Pace WD. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505-1518. doi: 10.1056/NEJMoa2118813. Epub 2022 Feb 26. PMID: 35213105; PMCID: PMC10367430.

  • Ugalde IC, Ratigan A, Merriman C, Cui J, Ericson B, Busse P, Carroll JK, Casale T, Celedon JC, Coyne-Beasley T, Fagan M, Fuhlbrigge AL, Villarreal GG, Hernandez PA, Jariwala S, Kruse J, Maher NE, Manning B, Mosnaim G, Nazario S, Pace WD, Phipatanakul W, Pinto-Plata V, Riley I, Rodriguez-Louis J, Salciccioli J, Shenoy K, Shields JB, Tarabichi Y, Sosa BT, Wechsler ME, Wisnivesky J, Yawn B, Israel E, Cardet JC. Preference for and impact of telehealth vs in-person asthma visits among Black and Latinx adults. Ann Allergy Asthma Immunol. 2023 Nov;131(5):614-627.e2. doi: 10.1016/j.anai.2023.07.012. Epub 2023 Jul 23.

    PubMed 37490981

  • Maldonado-Puebla M, Akenroye A, Busby J, Cardet JC, Louisias M. Pharmacoequity in Allergy-Immunology: Disparities in Access to Medications for Allergic Diseases and Proposed Solutions in the United States and Globally. J Allergy Clin Immunol Pract. 2024 Feb;12(2):272-280. doi: 10.1016/j.jaip.2023.11.005. Epub 2023 Nov 10.

    PubMed 37951413

  • Patadia R, Casale TB, Fowler J, Patel S, Cardet JC. Advancements in biologic therapy in eosinophilic asthma. Expert Opin Biol Ther. 2024 Apr;24(4):251-261. doi: 10.1080/14712598.2024.2342527. Epub 2024 Apr 23.

    PubMed 38619468

  • Inselman JW, Jeffery MM, Maddux JT, Shah ND, Rank MA. Trends and Disparities in Asthma Biologic Use in the United States. J Allergy Clin Immunol Pract. 2020 Feb;8(2):549-554.e1. doi: 10.1016/j.jaip.2019.08.024. Epub 2019 Aug 28.

    PubMed 31472294

  • National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.

    PubMed 17983880

  • Carr T, Tkacz J, Chung Y, Ambrose CS, Spahn J, Rane P, Wang Y, Lindsley AW, Lewing B, Burnette A. Gaps in Care Among Uncontrolled Severe Asthma Patients in the United States. J Allergy Clin Immunol Pract. 2024 Jul;12(7):1775-1782.e2. doi: 10.1016/j.jaip.2024.03.018. Epub 2024 Mar 18.

    PubMed 38508336

  • Ortega H, Bharmal N, Khatri S. Primary care referral patterns for patients with asthma: analysis of real-world data. J Asthma. 2023 Mar;60(3):609-615. doi: 10.1080/02770903.2022.2082308. Epub 2022 Jun 6.

    PubMed 35620831

  • Yaghoubi M, Adibi A, Safari A, FitzGerald JM, Sadatsafavi M. The Projected Economic and Health Burden of Uncontrolled Asthma in the United States. Am J Respir Crit Care Med. 2019 Nov 1;200(9):1102-1112. doi: 10.1164/rccm.201901-0016OC.

    PubMed 31166782

  • Nurmagambetov T, Kuwahara R, Garbe P. The Economic Burden of Asthma in the United States, 2008-2013. Ann Am Thorac Soc. 2018 Mar;15(3):348-356. doi: 10.1513/AnnalsATS.201703-259OC.

    PubMed 29323930

  • Dean BB, Calimlim BC, Sacco P, Aguilar D, Maykut R, Tinkelman D. Uncontrolled asthma: assessing quality of life and productivity of children and their caregivers using a cross-sectional Internet-based survey. Health Qual Life Outcomes. 2010 Sep 8;8:96. doi: 10.1186/1477-7525-8-96.

    PubMed 20825674

  • Most Recent National Asthma Data: Centers for Disease Control and Prevention; 2022 [Available from: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm.

  • Taunk ST, Cardet JC, Ledford DK. Clinical implications of asthma endotypes and phenotypes. Allergy Asthma Proc. 2022 Sep 1;43(5):375-382. doi: 10.2500/aap.2022.43.220047.

    PubMed 36065106

  • Ishmael L, Casale T, Cardet JC. Molecular Pathways and Potential Therapeutic Targets of Refractory Asthma. Biology (Basel). 2024 Aug 1;13(8):583. doi: 10.3390/biology13080583.

    PubMed 39194521

  • Buhl R, Bel E, Bourdin A, Davila I, Douglass JA, FitzGerald JM, Jackson DJ, Lugogo NL, Matucci A, Pavord ID, Wechsler ME, Kraft M. Effective Management of Severe Asthma with Biologic Medications in Adult Patients: A Literature Review and International Expert Opinion. J Allergy Clin Immunol Pract. 2022 Feb;10(2):422-432. doi: 10.1016/j.jaip.2021.10.059. Epub 2021 Nov 8.

    PubMed 34763123

Questions about this trial

What is this clinical trial studying?

A study testing ER-Initiated Telehealth Referral in people with Asthma Attack and Asthma Control, run by Juan Carlos Cardet 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 5 inclusion and 10 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 14 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Amanda McNamara, BA, LPN (813-396-2729, Alett1@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Completing an Asthma Specialist Follow-Up Visit Within 3 Months After Emergency Department Discharge (time frame: Within 3 months after emergency department discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07396987, which also lists 15 linked publications.

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 14 Sep 2026.

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