Bronchial AsthmaSURFENCT05632081
A Study of Step-up in Bronchial Asthma as a New End Point in Asthma Control (SURFE)
An observational study of Bronchial Asthma, run by Ain Shams University at 1 site in Saudi Arabia.
Trial summary
The goal of this observational study is to learn about the frequency needed for stepping-up treatment in patients with mild and moderate bronchial asthma. The main questions this study aims to answer are: What is the frequency and duration in which patients of asthma need to step up their treatment? Can the criteria… Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Bronchial Asthma
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 21 Aug 2024to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with confirmed mild to moderate asthma, aged 12 years and above, with no significant comorbidity/ies.
Who may be able to join
- Able to give written informed consent.
- Age above 12 years.
- Ability to use study inhalers correctly, use e-diary, and comply with study procedures and visits.
- Confirmed diagnosis of mild or moderate asthma asthma (based on GINA defined asthma control on a maximum of maintenance low dose ICS/LABA combination).
- Pre-bronchodilator ≥FEV1 60%.
- Reversibility test ≥12% or 200 ml from baseline.
- Non-smoker.
- For female subjects, non-pregnant and administer efficient contraception if in childbearing period.
Who cannot join
- Severe asthma exacerbation in last 3 months.
- Use of any systemic corticosteroids in last 12 weeks.
- Use of depot systemic steroids in last 12 weeks.
- Any concurrent respiratory disease as bronchiectasis, COPD, lung fibrosis, …
- Current or known history of tuberculosis in any organ.
- Current malignancy or any history of malignant disease for the past 5 years.
Show all 15Show fewer
- Subjects receiving any medications with known drug interaction with study medications.
- Use of beta-blockers including eye drops.
- Any significant concurrent disease as cardiac, hepatic, renal, …
- Current or history of alcohol or drug abuse.
- Current or history of significant psychiatric disease.
- Current or history of significant immunodefieciency.
- History of receiving any biological therapy for asthma for the last 3 years or currently eligible for any biological therapy for asthma.
- Subjects under any immuno-modulating therapy including biological therapy for any other indication. Subjects may be allowed to participate after 5 times half-live of the concerned drug.
- Any known allergy or contraindication to any of the study medications.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Security Forces Hospital Dammam
Dammam
HESHAM H RAAFAT, M.D., 00966592542751, hesham.raafat@med.asu.edu.eg
NAJLAA S ALAYED, MsC, head of RT
About this study
Official title: Study of Asthma Step-up in Real Life (SURFE)
The goal of this observational study is to learn about the frequency needed for stepping-up treatment in patients with mild and moderate bronchial asthma. The main questions this study aims to answer are:
- What is the frequency and duration in which patients of asthma need to step up their treatment?
- Can the criteria described in this study be applied and validated to test need for step up of asthma treatment? Participants will follow the treatment they are already receiving according to established guidelines and will be asked for regular visits for examination and spirometry. They will record symptoms score, each time they use the prescribed rescu inhaler, and morning and evening peak expiratory flow.
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, Asthma step-up, Asthma step-down, Asthma exacerbation, Mild asthma, Moderate asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized frequency of asthma step-up
Event in which the patient is considered eligible for step-up of asthma therapy. Any of the following is considered as asthma step-up:
- Use of reliever medication once daily or more for successive 7 days.
- Use of reliever medication for 2 times or more for successive 3 days.
- Any severe exacerbation as per protocol definition.
- Increase in weekly ACQ-5 score (with higher score means worse asthma control) by 0.5 or more points.
- Persistent decrease in PEF by 20% or more from baseline for 3 days or more.
Measured: 52 weeks
Secondary outcomes (3)
Annualized frequency of asthma step-down.
Event in which the patient is considered eligible for step-down of asthma therapy. All of the following is required for asthma step-down:
- Use of reliever medications 2 times or less weekly for at least 4 successive weeks.
- No severe exacerbation for 12 weeks or more.
- ACQ-5 score of 0.5 or less persistently for 4 successive weeks or more.
- PEF record with a variability of 10% or less for 4 successive weeks or more.
- No previously recorded deterioration as per asthma step-up definition for 12 weeks or more.
Measured: 52 weeks
Annualized rate of asthma severe exacerbation.
Continuous and/or abrupt worsening of asthma which require any of the following:
- Hospitalization for asthma exacerbation.
- ER visit with consequent administration of any form of systemic corticosteroids.
- Prescription of OCS for ≥3 days.
- Persistent decrease of PEF by 30% or more from baseline for 2 successive days or more.
Measured: 52 weeks
Annualized rate of asthma control weeks.
Asthma control weeks is measured by asthma control questionnaire-5 (ACQ-5) weekly, with higher score means worse asthma control.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start21 Aug 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Raafat, Ain Shams University
- Investigators
- Hesham H Raafat, M.D., Principal investigator, Security Forces Hospital Dammam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632081
- Sponsor's protocol ID
- SFHD001
- Acronym
- SURFE
- Status last verified
- Sep 2024
- First submitted
- 19 Nov 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Asthma Step-up in Real Life (SURFE)
- ClinicalTrials.gov ID
- NCT05632081
- Acronym / sponsor ID
- SURFE / SFHD001
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, Asthma step-up, Asthma step-down, Asthma exacerbation, Mild asthma, Moderate asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the frequency needed for stepping-up treatment in patients with mild and moderate bronchial asthma. The main questions this study aims to answer are:
- What is the frequency and duration in which patients of asthma need to step up their treatment?
- Can the criteria described in this study be applied and validated to test need for step up of asthma treatment? Participants will follow the treatment they are already receiving according to established guidelines and will be asked for regular visits for examination and spirometry. They will record symptoms score, each time they use the prescribed rescu inhaler, and morning and evening peak expiratory flow.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with confirmed mild to moderate asthma, aged 12 years and above, with no significant comorbidity/ies.
Key inclusion criteria (8 listed)
- Able to give written informed consent.
- Age above 12 years.
- Ability to use study inhalers correctly, use e-diary, and comply with study procedures and visits.
- Confirmed diagnosis of mild or moderate asthma asthma (based on GINA defined asthma control on a maximum of maintenance low dose ICS/LABA combination).
- Pre-bronchodilator ≥FEV1 60%.
Key exclusion criteria (15 listed)
- Severe asthma exacerbation in last 3 months.
- Use of any systemic corticosteroids in last 12 weeks.
- Use of depot systemic steroids in last 12 weeks.
- Any concurrent respiratory disease as bronchiectasis, COPD, lung fibrosis, …
- Current or known history of tuberculosis in any organ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Annualized frequency of asthma step-up
Time frame: 52 weeks
Event in which the patient is considered eligible for step-up of asthma therapy. Any of the following is considered as asthma step-up: 1. Use of reliever medication once daily or more for successive 7 days. 2. Use of reliever medication for 2 times or more for successive 3 days. 3. Any severe exacerbation as per protocol definition. 4. Increase in weekly ACQ-5 score (with higher score means worse asthma control) by 0.5 or more points. 5. Persistent decrease in PEF by 20% or more from baseline for 3 days or more.
3 secondary outcomes
Annualized frequency of asthma step-down.
Time frame: 52 weeks
Annualized rate of asthma severe exacerbation.
Time frame: 52 weeks
Annualized rate of asthma control weeks.
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hesham H Raafat, M.D. principal investigator
Security Forces Hospital Dammam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by Ain Shams University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hesham H Raafat, M.D. (00966592542751, hesham.raafat@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized frequency of asthma step-up (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.