Actively Recruiting
A Study of Step-up in Bronchial Asthma as a New End Point in Asthma Control (SURFE)
Led by Ain Shams University · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 and up to 80 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 with low dose ICS/LABA maintenance
- Pre-bronchodilator FEV1 of 60% or greater
- Reversibility test showing at least 12% or 200 ml improvement from baseline
- Non-smoker
- For female subjects, non-pregnant and using effective contraception if in childbearing period
You will not qualify if you...
- Severe asthma exacerbation in the last 3 months
- Use of any systemic corticosteroids in the last 12 weeks
- Use of depot systemic steroids in the last 12 weeks
- Any concurrent respiratory disease such as bronchiectasis, COPD, lung fibrosis
- Current or past tuberculosis in any organ
- Current malignancy or history of malignant disease in past 5 years
- Use of medications with known interactions with study drugs
- Use of beta-blockers including eye drops
- Significant concurrent diseases such as cardiac, hepatic, or renal problems
- Current or past alcohol or drug abuse
- Current or past significant psychiatric disease
- Current or past significant immunodeficiency
- History of biological therapy for asthma in last 3 years or current eligibility
- Use of immuno-modulating therapy including biologicals for other conditions unless past 5 half-lives
- Known allergy or contraindication to any study medications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Security Forces Hospital Dammam
Dammam, Saudi Arabia
Actively Recruiting
Research Team
H
Hesham H Raafat, M.D.
CONTACT
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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