Clinical trial NCT06201728: The Effect of Asthma Flare-up Clinic After Exacerbation
Official title: The Role of Asthma Flare-up Clinic in Improving Management and Outcomes of Asthma
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Asthma
Asthma Attack
Keywords: Asthma flare-up
Asthma management
clinic
pulmonologist
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: AstraZeneca
First posted: 2024-01-11
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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").
Primary purpose: PREVENTION

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. 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Exacerbations
timeFrame: During study follow-up (12 months from inclusion)
Secondary outcomes:
measure: Hospital arrival
timeFrame: During study follow-up (12 months from inclusion)
measure: Systemic steroids
timeFrame: During study follow-up (12 months from inclusion)
measure: Asthma control score
timeFrame: During study follow-up (12 months from inclusion)
measure: Quality of life score
timeFrame: During study follow-up (12 months from inclusion)
measure: Time to first exacerbation
timeFrame: During study follow-up (12 months from inclusion)
measure: Time to first hospital arrival
timeFrame: During study follow-up (12 months from inclusion)
measure: Time to first systemic steroids use
timeFrame: During study follow-up (12 months from inclusion)
measure: Clinical remission
timeFrame: During study follow-up (18 months from inclusion)
measure: Extended clinical remission
timeFrame: During study follow-up (18 months from inclusion)
measure: Percentage of Participants with errors of inhaler use technique
timeFrame: During study follow-up (18 months from inclusion)
measure: Percentage of Participants with a change in treatment
timeFrame: First clinic visit (1 month after inclusion)
measure: Adherent to treatment guidelines
timeFrame: During study follow-up (18 months from inclusion)
measure: Percentage of Participants with treatment compliance
timeFrame: During study follow-up (18 months from inclusion)
measure: Change in spirometry variables
timeFrame: During study follow-up (12 months from inclusion)
measure: Change in FeNO results
timeFrame: During study follow-up (12 months from inclusion)
measure: Change in area of reactance using IOS
timeFrame: During study follow-up (12 months from inclusion)
measure: Change in resonant frequency using IOS
timeFrame: During study follow-up (18 months from inclusion)
measure: Changes in respiratory resistance at 5 Hz, 20 Hz and the difference between 5 and 20 Hz using IOS
timeFrame: During study follow-up (12 months from inclusion)
measure: Changes in reactance at 5 Hz using IOS
timeFrame: During study follow-up (12 months from inclusion)
Other outcomes:
measure: asthma control test score - intervention
timeFrame: at inclusion and end of study among the intervention group.
measure: Analysis according to absolute peripheral eosinophils count
timeFrame: During study follow-up (18 months from inclusion)
measure: Exacerbations - pre-post
timeFrame: comparison during the intervention to the similar time frame before inclusion
measure: Systemic steroids - pre-post
timeFrame: comparison during the intervention to the similar time frame before inclusion
measure: Hospital admission - pre-post
timeFrame: comparison during the intervention to the similar time frame before inclusion
measure: Post-HOC analysis - exacerbations
timeFrame: At the extended duration from clinic follow-up - at 18 months
measure: Post-HOC analysis - hospital arrival due to asthma exacerbation
timeFrame: At the extended duration from clinic follow-up - at 18 months
measure: Post-HOC analysis - ACT score
timeFrame: At the extended duration from clinic follow-up - at 18 months
Locations:
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
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