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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
230
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.
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
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.
Time frame: During study follow-up (12 months from inclusion)
Hospital arrival
The rate of asthma exacerbations leading to hospital arrival between the intervention and control
Time frame: During study follow-up (12 months from inclusion)
Systemic steroids
The rate of systemic steroids use between the intervention and control
Time frame: During study follow-up (12 months from inclusion)
Asthma control score
Change in asthma control score between the intervention and control. Values range 5-25, with higher scores indicating better control.
Time frame: During study follow-up (12 months from inclusion)
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
Time frame: During study follow-up (12 months from inclusion)
Time to first exacerbation
Time to first asthma exacerbation between the intervention and control
Time frame: During study follow-up (12 months from inclusion)
Time to first hospital arrival
Time to first hospital arrival due to asthma exacerbation and from any cause between the intervention and control
Time frame: During study follow-up (12 months from inclusion)
Time to first systemic steroids use
Time to first systemic steroid use due to respiratory symptoms between the intervention and control
Time frame: During study follow-up (12 months from inclusion)
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.
Time frame: During study follow-up (18 months from inclusion)
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.
Time frame: During study follow-up (18 months from inclusion)
Percentage of Participants with errors of inhaler use technique
Errors of inhaler use technique in the intervention group between clinic visits
Time frame: During study follow-up (18 months from inclusion)
Percentage of Participants with a change in treatment
Change in treatment at the first clinic visit in the intervention group
Time frame: First clinic visit (1 month after inclusion)
Adherent to treatment guidelines
Treatment adhere to the Global Initiative for Asthma (GINA) guidelines based on disease severity, in the intervention vs. the control.
Time frame: During study follow-up (18 months from inclusion)
Percentage of Participants with treatment compliance
Compliance of inhaler treatment between the intervention and control
Time frame: During study follow-up (18 months from inclusion)
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.
Time frame: During study follow-up (12 months from inclusion)
Change in FeNO results
Change in exhaled nitric oxide test results (FeNO) in the intervention group, in parts per billion.
Time frame: During study follow-up (12 months from inclusion)
Change in area of reactance using IOS
Change in the area of reactance (AX) using Impulse oscillometry.
Time frame: During study follow-up (12 months from inclusion)
Change in resonant frequency using IOS
Change in the reactance resonant frequency (RF, measured in Hz) using Impulse oscillometry.
Time frame: During study follow-up (18 months from inclusion)
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.
Time frame: During study follow-up (12 months from inclusion)
Changes in reactance at 5 Hz using IOS
Change in the reactance at 5 Hz (X5) using Impulse oscillometry.
Time frame: During study follow-up (12 months from inclusion)
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