Understanding treatment adjustments in mild and moderate bronchial asthma

Study of Asthma Step-up in Real Life (SURFE)

This study looks at how often people with mild and moderate asthma need to change their treatment to see if their symptoms get worse.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 12 Years to 80 Years
• Sex: All
• Sponsor: Ain Shams University (other)
• Locations: 1 site (Dammam)
• Trial ID: NCT05632081 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate how often patients with mild and moderate bronchial asthma need to increase their treatment. Participants will continue their prescribed treatment while attending regular visits for examinations and spirometry tests. They will track their symptoms, use of rescue inhalers, and peak expiratory flow measurements. The study seeks to validate criteria for determining the need for treatment escalation in asthma management.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12 and older with a confirmed diagnosis of mild or moderate asthma who can comply with study procedures.

Not a fit: Patients with severe asthma exacerbations or concurrent respiratory diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved asthma management strategies and better control of symptoms for patients.

How similar studies have performed: While similar studies have explored asthma management, this specific approach to treatment step-up frequency is novel.

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.

Where this trial is running

Dammam

• Security Forces Hospital Dammam — Dammam, Saudi Arabia (RECRUITING)

Study contacts

• Principal investigator: Hesham H Raafat, M.D. — Security Forces Hospital Dammam
• Study coordinator: Hesham H Raafat, M.D.

Conditions: Bronchial Asthma, Bronchial asthma, Asthma step-up, Asthma step-down, Asthma exacerbation, Mild asthma, Moderate asthma