A Study of Step-up in Bronchial Asthma as a New End Point in Asthma Control (SURFE)
ConditionBronchial Asthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-80
SponsorAin Shams University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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, …
Trial population
Patients with confirmed mild to moderate asthma, aged 12 years and above, with no significant comorbidity/ies.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
52 weeksSecondary outcomes
1
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: 1. Use of reliever medications 2 times or less weekly for at least 4 successive weeks. 2. No severe exacerbation for 12 weeks or more. 3. ACQ-5 score of 0.5 or less persistently for 4 successive weeks or more. 4. PEF record with a variability of 10% or less for 4 successive weeks or more. 5. No previously recorded deterioration as per asthma step-up definition for 12 weeks or more.
Time frame
52 weeks2
Annualized rate of asthma severe exacerbation.
Continuous and/or abrupt worsening of asthma which require any of the following: 1. Hospitalization for asthma exacerbation. 2. ER visit with consequent administration of any form of systemic corticosteroids. 3. Prescription of OCS for ≥3 days. 4. Persistent decrease of PEF by 30% or more from baseline for 2 successive days or more.
Time frame
52 weeks3
Annualized rate of asthma control weeks.
Asthma control weeks is measured by asthma control questionnaire-5 (ACQ-5) weekly, with higher score means worse asthma control.
Time frame
52 weeksSponsors and contacts
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Source ClinicalTrials.gov