Asthma, Asthma Attack
Conditions
Keywords
Asthma flare-up, Asthma management, clinic, pulmonologist
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).
Interventions
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.
Sponsors
Tel-Aviv Sourasky Medical Center
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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").
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exacerbations | During study follow-up (12 months from inclusion) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital arrival | During study follow-up (12 months from inclusion) | The rate of asthma exacerbations leading to hospital arrival between the intervention and control |
| Systemic steroids | During study follow-up (12 months from inclusion) | The rate of systemic steroids use between the intervention and control |
| Asthma control score | During study follow-up (12 months from inclusion) | Change in asthma control score between the intervention and control. Values range 5-25, with higher scores indicating better control. |
| Quality of life score | During study follow-up (12 months from inclusion) | 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 to first exacerbation | During study follow-up (12 months from inclusion) | Time to first asthma exacerbation between the intervention and control |
| Time to first hospital arrival | During study follow-up (12 months from inclusion) | Time to first hospital arrival due to asthma exacerbation and from any cause between the intervention and control |
| Time to first systemic steroids use | During study follow-up (12 months from inclusion) | Time to first systemic steroid use due to respiratory symptoms between the intervention and control |
| Clinical remission | During study follow-up (18 months from inclusion) | 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. |
| Extended clinical remission | During study follow-up (18 months from inclusion) | 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. |
| Percentage of Participants with errors of inhaler use technique | During study follow-up (18 months from inclusion) | Errors of inhaler use technique in the intervention group between clinic visits |
| Percentage of Participants with a change in treatment | First clinic visit (1 month after inclusion) | Change in treatment at the first clinic visit in the intervention group |
| Adherent to treatment guidelines | During study follow-up (18 months from inclusion) | Treatment adhere to the Global Initiative for Asthma (GINA) guidelines based on disease severity, in the intervention vs. the control. |
| Percentage of Participants with treatment compliance | During study follow-up (18 months from inclusion) | Compliance of inhaler treatment between the intervention and control |
| Change in spirometry variables | During study follow-up (12 months from inclusion) | 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. |
| Change in FeNO results | During study follow-up (12 months from inclusion) | Change in exhaled nitric oxide test results (FeNO) in the intervention group, in parts per billion. |
| Change in area of reactance using IOS | During study follow-up (12 months from inclusion) | Change in the area of reactance (AX) using Impulse oscillometry. |
| Change in resonant frequency using IOS | During study follow-up (18 months from inclusion) | Change in the reactance resonant frequency (RF, measured in Hz) using Impulse oscillometry. |
| Changes in respiratory resistance at 5 Hz, 20 Hz and the difference between 5 and 20 Hz using IOS | During study follow-up (12 months from inclusion) | 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. |
| Changes in reactance at 5 Hz using IOS | During study follow-up (12 months from inclusion) | Change in the reactance at 5 Hz (X5) using Impulse oscillometry. |
Countries
Israel
Outcome results
None listed