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

NCT ID: NCT05632081

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-21
• Study Completion Date: 2026-03-30

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.

Conditions

Bronchial Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Hesham Raafat

A. professor chest medicine department, pulmonology consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hesham H Raafat, M.D.

Role: PRINCIPAL_INVESTIGATOR

Security Forces Hospital Dammam

Locations

Security Forces Hospital Dammam

Dammam, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Central Contacts

Hesham H Raafat, M.D.

Role: CONTACT

hesham.raafat@med.asu.edu.eg

00966592542751

Facility Contacts

HESHAM H RAAFAT, M.D.

Role: primary

hesham.raafat@med.asu.edu.eg

00966592542751

NAJLAA S ALAYED, MsC, head of RT

Role: backup

Other Identifiers

SFHD001

Identifier Type: -

Identifier Source: org_study_id