Asthma AcutePACTNCT07629830
Post Exacerbation Asthma Clinic Telecare Intervention to Reduce Recurrent Exacerbations
A study testing Follow-up in a remote flare-up clinic in people with Asthma Acute and Asthma Attack, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma Acute, Asthma Attack
- What is being tested?
- Follow-up in a remote flare-up clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presentation to the emergency department with an asthma exacerbation.
- Ability to complete telephone follow-up and access to a personal e-mail account.
- Agreement to participate in the study.
- Written or verbal informed consent according to study group assignment.
Who cannot join
- Uncontrolled cardiac disease.
- Any other uncontrolled medical condition.
- Inability to complete telephone follow-up.
- Pregnancy.
- Patients lacking decision-making capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv Sourasky Medical Center, Tel Aviv
Tel Aviv
Amir Bar-Shai, MD, +972-507265248, amirbs@tlvmc.gov.il
About this study
Official title: A Remote Clinic Intervention Following Hospital Discharge for Asthma Exacerbation to Reduce Recurrent Exacerbations
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:
Read more
- Intervention group - will undergo two structured remote pulmonology follow-up visits via secure video consultation within 7-21 days and 5 months after discharge, including treatment optimization, inhaler technique assessment, and self-management education.
- Control group - will continue standard community care without additional intervention.
All participants will complete scheduled follow-up assessments over 12 months, including evaluation of exacerbations, asthma control, healthcare utilization, and medication use.
Read the detailed description
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).
- Conditions
- Asthma Acute, Asthma Attack
- Being tested
- Follow-up in a remote flare-up clinic
- Keywords
- Asthma flare-up, Asthma management, remote clinic, pulmonologist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up in a remote flare-up clinicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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. |
| Remote Flare-Up Clinic | Experimental | 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. Receives: Other: Follow-up in a remote flare-up clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 3 months
Secondary outcomes (10)
Hospital Arrival due to asthma exacerbations
The rate of asthma exacerbations leading to hospital arrival between the intervention and control.
Measured: 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.
Measured: 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.
Measured: From enrollment to 3 months
Percentage of ≥1 asthma exacerbations
The percentage of patients in each study groups that had ≥1 asthma exacerbations.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For inclusion, all patients presenting to the emergency department at Tel Aviv Sourasky Medical Center with an asthma exacerbation will be identified weekly using the institutional electronic medical records system (Chameleon). The diagnosis of asthma exacerbation and eligibility for enrollment will be verified by a study pulmonologist. Eligible patients will be contacted by the research coordinator within one week of discharge, provided with information regarding the study, and asked for preliminary agreement to participate. Following informed consent, participants will undergo 1:1 randomization to either the intervention or control group using sealed identical envelopes prepared in advance. The intervention group will participate in structured remote pulmonology visits conducted 7-21 days and 5 months after discharge, while the control group will continue standard community care with follow-up assessments only.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- The Dalia and Eli Hurvitz Foundation Grant
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629830
- Sponsor's protocol ID
- 0034-26-TLV
- Acronym
- PACT
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No