A Study of Step-up in Bronchial Asthma as a New End Point in Asthma Control (SURFE)
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 criteri
| Condition(s) | Bronchial Asthma |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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, |
| Ages | 12 Years to 80 Years |
| Sex | All |
| Lead sponsor | Ain Shams University |
| Locations | Dammam, Saudi Arabia |
| Start date | 2024-08-21 |
| NCT ID | NCT05632081 |
| Official listing | https://clinicaltrials.gov/study/NCT05632081 |