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

Bronchial Asthma Clinical Trial

— SURFE  

Official title:

Study of Mild and Moderate Asthma Step-up in Real Life as a New Endpoint (SURFE)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05632081
• Other study ID #: SFHD001
• Status: Not yet recruiting
• Start date: March 10, 2024
• Est. completion date: May 2025

Study information

• Verified date: February 2024
• Source: Ain Shams University
• Contact: Hesham H Raafat, M.D.
• Phone: +966592542751
• Email: hesham.raafat[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized frequency of asthma step-up	Event in which the patient is considered eligible for step-up of asthma therapy. Any of the following is considered as asthma step-up: Use of reliever medication once daily or more for successive 7 days.; Use of reliever medication for 2 times or more for successive 3 days.; Any severe exacerbation as per protocol definition.; Increase in weekly ACQ-5 score by 0.5 or more points.; Persistent decrease in PEF by 20% or more from baseline for 3 days or more.	52 weeks
Secondary	Annualized frequency of asthma step-down.	Event in which the patient is considered eligible for step-down of asthma therapy. All of the following is required for asthma step-down: Use of reliever medications 2 times or less weekly for at least 4 successive weeks.; No severe exacerbation for 12 weeks or more.; ACQ-5 score of 0.5 or less persistently for 4 successive weeks or more.; PEF record with a variability of 10% or less for 4 successive weeks or more.; No previously recorded deterioration as per asthma step-up definition for 12 weeks or more.	52 weeks
Secondary	Annualized rate of asthma severe exacerbation.	Continuous and/or abrupt worsening of asthma which require any of the following: Hospitalization for asthma exacerbation.; ER visit with consequent administration of any form of systemic corticosteroids.; Prescription of OCS for =3 days.; Persistent decrease of PEF by 30% or more from baseline for 2 successive days or more.	52 weeks
Secondary	Annualized rate of asthma control weeks.	Asthma control weeks is measured by asthma control questionnaire-5 (ACQ-5) weekly.	52 weeks