An interventional study of Follow-up in a remote flare-up clinic in Asthma Acute and Asthma Attack, sponsored by Tel-Aviv Sourasky Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Treatment
Asthma exacerbations leading to emergency department visits or hospitalization are associated with a high risk of recurrent exacerbations, poor disease control, and increased healthcare utilization in the months following discharge. Early specialist follow-up during this vulnerable transition period remains limited, and many patients do not receive optimized long-term asthma management. The purpose of this study is to evaluate whether a structured remote asthma clinic intervention initiated shortly after hospital discharge can reduce recurrent exacerbations and improve asthma-related outcomes compared to standard community care.
This prospective randomized study will enroll 220 adult patients (18-75 years) presenting to the emergency department at Tel Aviv Sourasky Medical Center with an asthma exacerbation. Participants will be randomly assigned to one of two groups:
All participants will complete scheduled follow-up assessments over 12 months, including evaluation of exacerbations, asthma control, healthcare utilization, and medication use.
Data collection:
Participants will be followed for 12 months after enrollment. In the intervention group, remote clinic visits will be conducted 7-21 days after discharge and again 5 months after enrollment. In addition, follow-up phone calls will be conducted at 3 months, 9 months, and 12 months after enrollment. The control group will undergo follow-up phone calls at the same assessment time points, without remote clinic intervention.
Data collected will include recurrent exacerbations, systemic corticosteroid use, emergency department visits, hospitalizations, medication changes, rescue inhaler use, and asthma symptom burden assessed using the Asthma Control Test (ACT).
Participants will be randomized to their respective intervention groups using a secure system of sequentially numbered, opaque, sealed envelopes (SNOSE) containing the treatment assignments. To maintain strict allocation concealment and minimize selection bias, the entire randomization process will be managed exclusively by an independent study coordinator. The principal investigators and clinical research team members directly involved in participant enrollment, care, and data collection will have no involvement in the generation, maintenance, or opening of the assignment envelopes. The independent coordinator will open the designated envelope only after a participant has successfully completed the baseline assessment and met all eligibility criteria.
Sample Size Calculation:
Based on preliminary data, the average exacerbation rate during the first 3 months is expected to be 0.25 exacerbations per patient in the control group and 0.10 in the intervention group. To detect this difference with 80% power and a significance level of 0.05, 100 participants are required in each group. Assuming a 10% loss to follow up, the planned sample size is 220 participants (110 participants per group).
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 220 is above the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the control group will continue standard community-based medical care following discharge from the emergency department or hospitalization for asthma exacerbation, without additional remote pulmonology intervention. Follow-up assessments will be conducted by the research coordinator at predefined time points for study outcome evaluation only.
Participants in the intervention group will undergo structured remote pulmonology follow-up through secure video consultations conducted 7-21 days and 5 months after discharge following an asthma exacerbation. The remote visits will include assessment of asthma control and exacerbation history, inhaler technique evaluation, treatment optimization according to current guidelines, and asthma self-management education. Visit summaries and treatment recommendations will be documented in the electronic medical record and provided to the participant. Additional follow-up phone assessments will be conducted by the research coordinator at predefined time points for study outcome evaluation.
Other: Follow-up in a remote flare-up clinic
Participants assigned to the intervention group will undergo two structured remote pulmonology visits via secure video consultation, conducted 7-21 days and 5 months after discharge following an asthma exacerbation. The intervention will include assessment of asthma control and exacerbation history, inhaler technique evaluation, treatment optimization, and asthma self-management education according to current guidelines. Additional follow-up phone assessments will be conducted at 3, 9, and 12 months for study outcome evaluation only.
Asthma Exacerbations Rate
The primary outcome will be the rate of severe asthma exacerbations, assessed as the total number of severe asthma exacerbations following enrollment divided by the number of participants in each study group. The primary analysis will be performed according to the intention-to-treat principle. severe asthma exacerbations defined as worsening asthma requiring treatment with systemic glucocorticoids for at least 3 days or worsening symptoms leading to an emergency department visit or hospitalization.
Time frame: From enrollment to 3 months
Hospital Arrival due to asthma exacerbations
The rate of asthma exacerbations leading to hospital arrival between the intervention and control.
Time frame: From enrollment to 3 months
Change in Asthma Control Test (ACT) score
Change in asthma control score from baseline to 3 months between the intervention and control. Values range 5-25, with higher scores indicating better control.
Time frame: From enrollment to 3 months
Adherent to Treatment Guidelines
Treatment adhere to the Global Initiative for Asthma (GINA) guidelines based on disease severity, in the intervention vs. the control. This will be defined as the percentage of patients taking the GINA-recommended inhaled corticosteroid dose, as self-reported in the 3-months follow-up.
Time frame: From enrollment to 3 months
Percentage of ≥1 asthma exacerbations
The percentage of patients in each study groups that had ≥1 asthma exacerbations.
Time frame: From enrollment to 3 months
Asthma Exacerbations Rate - extended follow-up
The primary outcome will be the rate of severe asthma exacerbations, assessed as the total number of severe asthma exacerbations following enrollment divided by the number of participants in each study group. The primary analysis will be performed according to the intention-to-treat principle. severe asthma exacerbations defined as worsening asthma requiring treatment with systemic glucocorticoids for at least 3 days or worsening symptoms leading to an emergency department visit or hospitalization.
Time frame: From enrollment to 12 months
Hospital Arrival due to asthma exacerbations - extended follow-up
The rate of asthma exacerbations leading to hospital arrival between the intervention and control.
Time frame: From enrollment to 12 months
Change in Asthma Control Test (ACT) score - extended follow-up
Change in asthma control score from baseline to 12 months between the intervention and control. Values range 5-25, with higher scores indicating better control.
Time frame: From enrollment to 12 months
Adherent to Treatment Guidelines - extended follow-up
Treatment adhere to the Global Initiative for Asthma (GINA) guidelines based on disease severity, in the intervention vs. the control. This will be defined as the percentage of patients taking the GINA-recommended inhaled corticosteroid dose, as self-reported in the 12-months follow-up.
Time frame: From enrollment to 12 months
Exacerbation Frequency
Change in exacerbation frequency during the first year following enrollment compared to the year prior to study enrollment, defined as the percentage change in the rate of severe asthma exacerbations before and after the intervention.
Time frame: From 12 months prior to enrollment through 12 months following enrollment.
Percentage of ≥1 asthma exacerbations - extended follow-up
The percentage of patients in each study groups that had ≥1 asthma exacerbations.
Time frame: From enrollment to 12 months
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