The Effect of Asthma Flare-up Clinic After Exacerbation

Tel Aviv Sourasky Medical Center

Status: Invitation-only

Conditions: Asthma Attack; Asthma

Treatments: Other: Follow-up in a flare-up clinic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06201728

0714-23-TLV

Details and patient eligibility

About

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.

Full 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 12 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).

Enrollment: 230 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Other: Follow-up in a flare-up clinic

Control

No Intervention group

Description:

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.