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

NCT05632081 | Recruiting

• 1 other identifier: SFHD001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Bronchial asthma; Asthma step-up; Asthma step-down; Asthma exacerbation; Mild asthma; Moderate asthma

Outcome Measures

Primary Outcomes (1)

• 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: 1. Use of reliever medication once daily or more for successive 7 days. 2. Use of reliever medication for 2 times or more for successive 3 days. 3. Any severe exacerbation as per protocol definition. 4. Increase in weekly ACQ-5 score (with higher score means worse asthma control) by 0.5 or more points. 5. Persistent decrease in PEF by 20% or more from baseline for 3 days or more.

  52 weeks

Secondary Outcomes (3)

• Annualized frequency of asthma step-down.

  52 weeks

• Annualized rate of asthma severe exacerbation.

  52 weeks

• Annualized rate of asthma control weeks.

  52 weeks

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed mild to moderate asthma, aged 12 years and above, with no significant comorbidity/ies.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Security Forces Hospital Dammam

Dammam, Saudi Arabia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

CBC, total IgE in some patients.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Hesham H Raafat, M.D.

  Security Forces Hospital Dammam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hesham H Raafat, M.D.

CONTACT

00966592542751; hesham.raafat@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A. professor chest medicine department, pulmonology consultant

Study Record Dates

• First Submitted: November 19, 2022
• First Posted: November 30, 2022
• Study Start: August 21, 2024
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

SA (1)