The Effect of Asthma Flare-up Clinic After Exacerbation

NCT06201728 | Enrolling By Invitation

• 1 other identifier: 0714-23-TLV
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to examine the effect of asthma flare-up clinic follow-up in adult subjects after an asthma flare-up. This study aim to answer the following questions:

1. 1.Does a follow-up in a flare-up clinic improves disease outcomes?
2. 2.Does a follow-up in a flare-up clinic improves disease management?

Conditions

Asthma; Asthma Attack

Keywords

Asthma flare-up; Asthma management; clinic; pulmonologist

Outcome Measures

Primary Outcomes (1)

• Exacerbations

  The rate of severe asthma exacerbations between the intervention and control, defined as a deterioration of asthma leading to treatment for 3 days or more with systemic glucocorticoids or hospitalization or an emergency department visit leading to treatment with systemic glucocorticoids.

  During study follow-up (12 months from inclusion)

Secondary Outcomes (19)

• Hospital arrival

  During study follow-up (12 months from inclusion)

• Systemic steroids

  During study follow-up (12 months from inclusion)

• Asthma control score

  During study follow-up (12 months from inclusion)

• Quality of life score

  During study follow-up (12 months from inclusion)

• Time to first exacerbation

  During study follow-up (12 months from inclusion)

Other Outcomes (8)

• asthma control test score - intervention

  at inclusion and end of study among the intervention group.

• Analysis according to absolute peripheral eosinophils count

  During study follow-up (18 months from inclusion)

• Exacerbations - pre-post

  comparison during the intervention to the similar time frame before inclusion

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention will include 3 follow-up visits in the flare up clinic - one month after hospital discharge (from ED or admission), 3 months after the first visit, 6 months after the second visit. At 12 and 18 months after the first visit there will be an additional phone-call with structured interview. Each clinic visit will include: i. Pulmonologist examination, review of disease state and care, and adjustment of treatment. ii. Vital signs (blood pressure, saturation in room air, pulse). iii. Blood sample for complete blood count. iv. Filling Asthma Quality of Life Questionnaire (AQLQ). v. Spirometry. vi. Impulse oscillometry and FeNO tests. vii. Arrangement of next follow-up visit.

Other: Follow-up in a flare-up clinic

Control

NO INTERVENTION

The control group will undergo 4 phone-call follow-ups with structured interview based on a predefined questionnaire, at the following time frames - 1, 4, 10, 13, and 19 months after hospital discharge. Each follow-up call will include: i. Assessment of ACT score. ii. Whether they attend pulmonologist follow-up visit, additional evaluations (IOS or spirometry), and interventions (pulmonary rehabilitation and smoking cessation programs). iii. Current treatment. iv. Asthma exacerbations, use of systemic steroids, and relevant management.

Interventions

Follow-up in a flare-up clinic OTHER

Follow-up in the clinic based on the time frame specified above. Additional interventions during the clinic visit, other than specified above, includes: An overview by a pulmonologist of new exacerbations, systemic steroid use, or other hospitalizations, active medications and compliance to treatment, inhaler using technique, possible medication side-effects, and the asthma control test (ACT) score. The physician will provide information on smoking cessation when relevant and pulmonary rehabilitation. In addition, decision on change of treatment and further evaluations outside of the clinic, including initiation of biologic treatment.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior asthma diagnosis based on clinical and spirometry accepted criteria.
• Acute exacerbation of asthma as the main reason for ED arrival.
• Ability to perform in-person and telephone follow-up.
• Agree to participate, with a signed or verbal informed consent, according to the study group.

You may not qualify if:

• Uncontrolled comorbidity.
• Cognitive dysfunction.
• Patients under 18 years or above 75 years.
• Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (6)

• McDonald VM, Gibson PG. Exacerbations of severe asthma. Clin Exp Allergy. 2012 May;42(5):670-7. doi: 10.1111/j.1365-2222.2012.03981.x.

  PMID: 22515389 BACKGROUND

• Mincheva R, Ekerljung L, Bossios A, Lundback B, Lotvall J. High prevalence of severe asthma in a large random population study. J Allergy Clin Immunol. 2018 Jun;141(6):2256-2264.e2. doi: 10.1016/j.jaci.2017.07.047. Epub 2017 Sep 20.

  PMID: 28939411 BACKGROUND

• Naqvi M, Khachi H. The barriers to accessing primary care resulting in hospital presentation for exacerbation of asthma or chronic obstructive pulmonary disease in a large teaching hospital in London. Respir Med. 2016 Aug;117:162-5. doi: 10.1016/j.rmed.2016.05.020. Epub 2016 May 27.

  PMID: 27492527 BACKGROUND

• Zhang X, Lai Z, Qiu R, Guo E, Li J, Zhang Q, Li N. Positive change in asthma control using therapeutic patient education in severe uncontrolled asthma: a one-year prospective study. Asthma Res Pract. 2021 Jul 21;7(1):10. doi: 10.1186/s40733-021-00076-y.

  PMID: 34289896 BACKGROUND

• Hsu J, Wilhelm N, Lewis L, Herman E. Economic Evidence for US Asthma Self-Management Education and Home-Based Interventions. J Allergy Clin Immunol Pract. 2016 Nov-Dec;4(6):1123-1134.e27. doi: 10.1016/j.jaip.2016.05.012. Epub 2016 Sep 19.

  PMID: 27658535 BACKGROUND

• Goeman D, Jenkins C, Crane M, Paul E, Douglass J. Educational intervention for older people with asthma: a randomised controlled trial. Patient Educ Couns. 2013 Dec;93(3):586-95. doi: 10.1016/j.pec.2013.08.014. Epub 2013 Aug 19.

  PMID: 24007766 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: For inclusion, each week, all patients that were discharged from the hospital an adhere to the inclusion criteria will be identified using an electronic medical records software (Chameleon) and a list with their details will be created. The diagnosis of asthma and of the exacerbation will be verified by senior pulmonologist. Following that, the research coordinator will contact each subject with details on the study and a preliminary acceptance for inclusion. After acceptance, the randomization will be performed manually by randomly choosing from 200 identical envelops (100 with printed "intervention" and 100 with "control").

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)