Actively Recruiting
Study of Asthma Step-up in Real Life (SURFE)
Led by Ain Shams University · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing patients with mild to moderate bronchial asthma to understand how often and for how long they need to increase their treatment. The study aims to validate criteria that identify when patients should step up their asthma treatment. Participants continue their current asthma treatment based on established guidelines while the researchers track their symptoms and lung function over time. Participants will maintain their usual asthma treatment and will attend regular study visits for examinations and lung function tests, including spirometry. They will also keep records of their symptom scores, use of rescue inhalers, and morning and evening peak expiratory flow. This data will help assess treatment adjustments in real life. Throughout the 52-week study period, participants will be monitored for how frequently they step up or step down their asthma treatment, the rate of severe asthma attacks, and the number of weeks they maintain asthma control. Researchers will gather this information through regular visits and symptom tracking to better understand asthma management. The study is sponsored by Ain Shams University and includes participants aged 12 to 80 years.
CONDITIONS
Brief Title
A Study of Step-up in Bronchial Asthma as a New End Point in Asthma Control (SURFE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 based on GINA control on low dose ICS/LABA.
- Pre-bronchodilator FEV1 60% or more.
- Reversibility test showing 12% or more improvement or 200 ml increase from baseline.
- Non-smoker.
- For females, non-pregnant and using effective contraception if of childbearing age.
You will not qualify if you...
- Severe asthma exacerbation in last 3 months.
- Use of systemic corticosteroids or depot steroids in last 12 weeks.
- Any other respiratory disease such as bronchiectasis, COPD, or lung fibrosis.
- Current or past tuberculosis in any organ.
- Current or history of malignancy in the past 5 years.
- Use of medications that interact with study drugs.
- Use of beta-blockers including eye drops.
- Any significant heart, liver, or kidney disease.
- History of alcohol or drug abuse.
- Significant psychiatric disease.
- Significant immunodeficiency.
- Previous biological therapy for asthma in last 3 years or eligibility for such therapy.
- Ongoing immuno-modulating therapy, including biologicals for other conditions unless enough time has passed.
- Known allergy or contraindication to study medications.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants are observed to track the frequency of asthma step-up, step-down, severe exacerbations, and asthma control weeks over one year.
Periodic visits throughout the year
Trial Site Locations
Total: 1 location
1
Security Forces Hospital Dammam
Dammam, Saudi Arabia
Actively Recruiting
Research Team
H
Hesham H Raafat, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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