A randomized, double-blind, placebo-controlled, study to determine the added value of vitamin D3 to treatment with subcutaneous immunotherapy (SCIT) in patients with moderate to severe allergic rhinitis/ rhinoconjunctivitis caused by birch pollen - Added value of Vitamin D3 to SCIT

Academisch Medisch Centrum0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月15日

研究概览

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•1. Signed informed consent
•2. Age *18 * 65 years
•3. Moderate to severe birch-pollen-induced AR/ARC of at least 2 years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines (Appendix 1, see manual) with or without concomitant mild to moderate persistent asthma
•4. FEV1>70% for patients with a history of asthma, FEV1>70% or PEF>80% for patients without a history of asthma
•5. A positive SPT (mean wheal diameter * 3mm compared to negative control and negative control should be negative) for birch pollen assessed within 1 year before randomization
•6. A positive ImmunoCAP (>0.7 kU/L) for birch pollen

•1. Clinically relevant co-sensitization (others than hazel, alder and elm) expected during the birch-pollen season.
•2. Chronic asthma with an FEV1<70 % of predicted value.
•3. History of AIT (SCIT or SLIT) with any allergen within the past 5 years
•4. Ongoing AIT (SCIT or SLIT) with any allergen(s) during the study period
•5. Current Treatment with VD3 analogue.
•6. Vaccination within one week before or during the treatment phase.
•7. Immunosuppressive or biological medication (e.g. IL-5, anti-IgE therapy) within the last six months prior to inclusion and up to end of trial (EoT).
•8. Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs.
•9. Uncontrolled asthma or other active respiratory diseases.
•For the rest of the exclusion criteria see protocol

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