ClinConnect ClinConnect Logo
Search / Trial NCT05632081

A Study of Step-up in Bronchial Asthma as a New End Point in Asthma Control (SURFE)

Launched by AIN SHAMS UNIVERSITY · Nov 19, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Bronchial Asthma Asthma Step Up Asthma Step Down Asthma Exacerbation Mild Asthma Moderate Asthma

ClinConnect Summary

This clinical trial, called SURFE, is designed to learn more about how often patients with mild to moderate bronchial asthma need to increase their treatment. The researchers want to find out how frequently and for how long patients might need to step up their medications to better manage their asthma symptoms. Participants will continue with their current treatment plan, which follows established guidelines, and will visit the clinic regularly. During these visits, they will undergo examinations, perform breathing tests, and keep track of their symptoms and use of rescue inhalers.

To be eligible for this study, participants should be over 12 years old, have a confirmed diagnosis of mild or moderate asthma, and be able to follow study procedures, including using an inhaler correctly. It's important for potential participants to know that those with severe asthma attacks in the past three months or certain other medical conditions may not be able to join the study. Overall, this trial aims to improve asthma management and help healthcare providers understand the best ways to adjust treatments based on patients' needs.

Gender

ALL

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.

About Ain Shams University

Ain Shams University, established in Cairo, Egypt, is a prestigious higher education institution renowned for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise in various medical and scientific disciplines to advance healthcare through rigorous research initiatives. With a focus on ethical practices and adherence to regulatory standards, Ain Shams University aims to contribute to the development of new therapies and improve patient outcomes, fostering collaboration among researchers, healthcare professionals, and industry partners in the pursuit of medical advancements.

Locations

Dammam, , Saudi Arabia

Patients applied

0 patients applied

Trial Officials

Hesham H Raafat, M.D.

Principal Investigator

Security Forces Hospital Dammam

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials