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

Inclusion criteria

• 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.

Exclusion criteria

• 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.