AsthmaNCT06201728
The Effect of Asthma Flare-up Clinic After Exacerbation
A study testing Follow-up in a flare-up clinic in people with Asthma and Asthma Attack, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma, Asthma Attack
- What is being tested?
- Follow-up in a flare-up clinic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2024to 31 Dec 2026
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Asthma Flare-up Clinic in Improving Management and Outcomes of Asthma
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:
- Does a follow-up in a flare-up clinic improves disease outcomes?
- Does a follow-up in a flare-up clinic improves disease management?
Read more
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.
Read the 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).
- Conditions
- Asthma, Asthma Attack
- Being tested
- Follow-up in a flare-up clinic
- Keywords
- Asthma flare-up, Asthma management, clinic, pulmonologist
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up in a flare-up clinicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention will include 3 follow-up visits in the flare up clinic - one month after hospital discharge (from ED or admission), 3 months after the first visit, 6 months after the second visit. At 12 and 18 months after the first visit there will be an additional phone-call with structured interview.
Each clinic visit will include:
i. Pulmonologist examination, review of disease state and care, and adjustment of treatment.
ii. Vital signs (blood pressure, saturation in room air, pulse). iii. Blood sample for complete blood count. iv. Filling Asthma Quality of Life Questionnaire (AQLQ). v. Spirometry. vi. Impulse oscillometry and FeNO tests. vii. Arrangement of next follow-up visit. Receives: Other: Follow-up in a flare-up clinic |
| Control | No intervention | The control group will undergo 4 phone-call follow-ups with structured interview based on a predefined questionnaire, at the following time frames - 1, 4, 10, 13, and 19 months after hospital discharge. Each follow-up call will include: i. Assessment of ACT score. ii. Whether they attend pulmonologist follow-up visit, additional evaluations (IOS or spirometry), and interventions (pulmonary rehabilitation and smoking cessation programs). iii. Current treatment. iv. Asthma exacerbations, use of systemic steroids, and relevant management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During study follow-up (12 months from inclusion)
Secondary outcomes (19)
Hospital arrival
The rate of asthma exacerbations leading to hospital arrival between the intervention and control
Measured: During study follow-up (12 months from inclusion)
Systemic steroids
The rate of systemic steroids use between the intervention and control
Measured: 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.
Measured: 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
Measured: During study follow-up (12 months from inclusion)
Time to first exacerbation
Time to first asthma exacerbation between the intervention and control
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: During study follow-up (18 months from inclusion)
Percentage of Participants with treatment compliance
Compliance of inhaler treatment between the intervention and control
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During study follow-up (12 months from inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 May 2024
- Primary completion18 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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").
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201728
- Sponsor's protocol ID
- 0714-23-TLV
- Status last verified
- Jun 2026
- First submitted
- 1 Jan 2024
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McDonald VM, Gibson PG. Exacerbations of severe asthma. Clin Exp Allergy. 2012 May;42(5):670-7. doi: 10.1111/j.1365-2222.2012.03981.x.
PubMed 22515389Mincheva R, Ekerljung L, Bossios A, Lundback B, Lotvall J. High prevalence of severe asthma in a large random population study. J Allergy Clin Immunol. 2018 Jun;141(6):2256-2264.e2. doi: 10.1016/j.jaci.2017.07.047. Epub 2017 Sep 20.
PubMed 28939411Naqvi M, Khachi H. The barriers to accessing primary care resulting in hospital presentation for exacerbation of asthma or chronic obstructive pulmonary disease in a large teaching hospital in London. Respir Med. 2016 Aug;117:162-5. doi: 10.1016/j.rmed.2016.05.020. Epub 2016 May 27.
PubMed 27492527Zhang X, Lai Z, Qiu R, Guo E, Li J, Zhang Q, Li N. Positive change in asthma control using therapeutic patient education in severe uncontrolled asthma: a one-year prospective study. Asthma Res Pract. 2021 Jul 21;7(1):10. doi: 10.1186/s40733-021-00076-y.
PubMed 34289896Hsu J, Wilhelm N, Lewis L, Herman E. Economic Evidence for US Asthma Self-Management Education and Home-Based Interventions. J Allergy Clin Immunol Pract. 2016 Nov-Dec;4(6):1123-1134.e27. doi: 10.1016/j.jaip.2016.05.012. Epub 2016 Sep 19.
PubMed 27658535Goeman D, Jenkins C, Crane M, Paul E, Douglass J. Educational intervention for older people with asthma: a randomised controlled trial. Patient Educ Couns. 2013 Dec;93(3):586-95. doi: 10.1016/j.pec.2013.08.014. Epub 2013 Aug 19.
PubMed 24007766