The Effect of Asthma Flare-up Clinic After Exacerbation

Asthma Clinical Trial

Official title:

The Role of Asthma Flare-up Clinic in Improving Management and Outcomes of Asthma

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06201728
• Other study ID #: 0714-23-TLV
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: May 2024
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Does a follow-up in a flare-up clinic improves disease outcomes?

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

Participants in the intervention group will take part in a structured follow-up at the asthma flare-up clinic at three time points. Each visit will include questionnaires, pulmonologist examination and consultation, laboratory tests and spirometry. The control group will undergo phone-call follow-up with a research coordinator in similar time frames as the intervention.

Researchers will compare the two groups to see if the clinic follow-up affects the study outcomes.

Description:

The primary outcomes will be analyzed as total exacerbations during the time frame and as a time-dependent variable (time to exacerbation) using Kaplan Meier survival analysis. Additional sub-analyses will be made for the type of inclusion setting (ED/hospitalization), number of prior exacerbations, and eosinophil count. Additional analyses will be made for all secondary outcomes. Analyses relevant only for the intervention group (such as spirometry and IOS) will compare results to the first follow-up visit. A cost-effectiveness analysis will be made, comparing the follow-up cost and the cost saved by exacerbation reduction based on the final results.

Sample size calculation - The invetigators assume based on previous research that the intervention will lead to a 20% decrease in exacerbations during the 18 months from first follow-up. To achieve an alpha of 0.05 and a power of 80%, there is a need for 88 patients in each group. Assuming a loss-to-follow-up rate (missing to complete at least 2 clinic visits or loss to phone follow-up) of 20%, the study will need 115 patients in each group (230 overall).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 230
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Asthma
• Asthma Attack

Intervention

Other:
• Follow-up in a flare-up clinic
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.

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	AstraZeneca

Country where clinical trial is conducted

Israel, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	asthma control test score - intervention	Asthma control test score. Values range 5-25, with higher scores indicating better control.	at inclusion and end of study among the intervention group.
Other	Analysis according to absolute peripheral eosinophils count	Analysis of the primary outcome base on eosinophil levels above or below 300 and 150 (as measured prior to study inclusion without steroid treatment).	During study follow-up (18 months from inclusion)
Other	Exacerbations - pre-post	The rate of severe asthma exacerbations, 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.	comparison during the intervention to the similar time frame before inclusion
Other	Systemic steroids - pre-post	The rate of systemic steroids use	comparison during the intervention to the similar time frame before inclusion
Other	Hospital admission - pre-post	The rate of asthma exacerbations leading to hospital arrival between the intervention and control	comparison during the intervention to the similar time frame before inclusion
Primary	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 (18 months from inclusion)
Secondary	Hospital arrival	The rate of asthma exacerbations leading to hospital arrival between the intervention and control	During study follow-up (18 months from inclusion)
Secondary	Systemic steroids	The rate of systemic steroids use between the intervention and control	During study follow-up (18 months from inclusion)
Secondary	Asthma control score	Change in asthma control score between the intervention and control. Values range 5-25, with higher scores indicating better control.	During study follow-up (18 months from inclusion)
Secondary	Quality of life score	Change in Asthma Quality of Life Questionnaire score in the intervention group. Values range 7-224, with higher scores indicating better quality of life	During study follow-up (18 months from inclusion)
Secondary	Time to first exacerbation	Time to first asthma exacerbation between the intervention and control	During study follow-up (18 months from inclusion)
Secondary	Time to first hospital arrival	Time to first hospital arrival due to asthma exacerbation and from any cause between the intervention and control	During study follow-up (18 months from inclusion)
Secondary	Time to first systemic steroids use	Time to first systemic steroid use due to respiratory symptoms between the intervention and control	During study follow-up (18 months from inclusion)
Secondary	Clinical remission	Rate of clinical remission for at least 12 months, defined as a period without exacerbations, need of systemic steroids, and an ACT above or equal to 20.	During study follow-up (18 months from inclusion)
Secondary	Extended clinical remission	Rate of extended clinical remission for at least 12 months, defined as above, with additional spirometry criteria - FEV1 after bronchodilators equal/above 80% or increase of 100 ml of pre-bronchodilator FEV1 from baseline.	During study follow-up (18 months from inclusion)
Secondary	Percentage of Participants with errors of inhaler use technique	Errors of inhaler use technique in the intervention group between clinic visits	During study follow-up (18 months from inclusion)
Secondary	Percentage of Participants with a change in treatment	Change in treatment at the first clinic visit in the intervention group	First clinic visit (1 month after inclusion)
Secondary	Adherent to treatment guidelines	Treatment adhere to the Global Initiative for Asthma (GINA) guidelines based on disease severity, in the intervention vs. the control.	During study follow-up (18 months from inclusion)
Secondary	Percentage of Participants with treatment compliance	Compliance of inhaler treatment between the intervention and control	During study follow-up (18 months from inclusion)
Secondary	Change in spirometry variables	Change in spirometry variables in the intervention group, including forced expiratory volume (FEV1) in liters and %predicted, Forced vital capacity (FVC) in liters and %predicted.	During study follow-up (18 months from inclusion)
Secondary	Change in FeNO results	Change in exhaled nitric oxide test results (FeNO) in the intervention group, in parts per billion.	During study follow-up (18 months from inclusion)
Secondary	Change in area of reactance using IOS	Change in the area of reactance (AX) using Impulse oscillometry.	During study follow-up (18 months from inclusion)
Secondary	Change in resonant frequency using IOS	Change in the reactance resonant frequency (RF, measured in Hz) using Impulse oscillometry.	During study follow-up (18 months from inclusion)
Secondary	Changes in respiratory resistance at 5 Hz, 20 Hz and the difference between 5 and 20 Hz using IOS	Change in respiratory resistance at 5 Hz (R5, measured in kPa/L/s) and 20 Hz (R20, measured in kPa/L/s), the difference between R5 and R20 (R5-R20, measured in kPa/L/s) using Impulse oscillometry.	During study follow-up (18 months from inclusion)
Secondary	Changes in reactance at 5 Hz using IOS	Change in the reactance at 5 Hz (X5) using Impulse oscillometry.	During study follow-up (18 months from inclusion)