Clinical trial NCT05632081: A Study of Step-up in Bronchial Asthma as a New End Point in Asthma Control (SURFE)
Official title: Study of Asthma Step-up in Real Life (SURFE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchial Asthma
Keywords: Bronchial asthma
Asthma step-up
Asthma step-down
Asthma exacerbation
Mild asthma
Moderate asthma
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed mild to moderate asthma, aged 12 years and above, with no significant comorbidity/ies.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Able to give written informed consent.
2. Age above 12 years.
3. Ability to use study inhalers correctly, use e-diary, and comply with study procedures and visits.
4. Confirmed diagnosis of mild or moderate asthma asthma (based on GINA defined asthma control on a maximum of maintenance low dose ICS/LABA combination).
5. Pre-bronchodilator ≥FEV1 60%.
6. Reversibility test ≥12% or 200 ml from baseline.
7. Non-smoker.
8. For female subjects, non-pregnant and administer efficient contraception if in childbearing period.

Exclusion Criteria:

1. Severe asthma exacerbation in last 3 months.
2. Use of any systemic corticosteroids in last 12 weeks.
3. Use of depot systemic steroids in last 12 weeks.
4. Any concurrent respiratory disease as bronchiectasis, COPD, lung fibrosis, ...
5. Current or known history of tuberculosis in any organ.
6. Current malignancy or any history of malignant disease for the past 5 years.
7. Subjects receiving any medications with known drug interaction with study medications.
8. Use of beta-blockers including eye drops.
9. Any significant concurrent disease as cardiac, hepatic, renal, ...
10. Current or history of alcohol or drug abuse.
11. Current or history of significant psychiatric disease.
12. Current or history of significant immunodefieciency.
13. History of receiving any biological therapy for asthma for the last 3 years or currently eligible for any biological therapy for asthma.
14. 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.
15. Any known allergy or contraindication to any of the study medications.

Primary outcomes:
measure: Annualized frequency of asthma step-up
timeFrame: 52 weeks
Secondary outcomes:
measure: Annualized frequency of asthma step-down.
timeFrame: 52 weeks
measure: Annualized rate of asthma severe exacerbation.
timeFrame: 52 weeks
measure: Annualized rate of asthma control weeks.
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Security Forces Hospital Dammam
Study officials:
affiliation: Security Forces Hospital Dammam
name: Hesham H Raafat, M.D.
role: PRINCIPAL_INVESTIGATOR
References: