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 polle

Phase 2

Completed

Conditions: 10046304
hayfever
allergic rhinitis

Registration Number: NL-OMON46004

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is the assessment of serological and cellular<br /><br>immunological changes and kinetics thereof induced by SCIT with VD3 compared to<br /><br>SCIT alone in patients with moderate to severe allergic<br /><br>rhinitis/rhino-conjunctivitis caused by birch pollen in a pre-seasonal<br /><br>short-term course of SCIT.<br /><br>Amongst the immunological outcomes, IL-10 production by PBMCs in response to<br /><br>allergen-specific stimulation after 5 weeks of treatment with VD3 analogue<br /><br>Zemplar® compared to placebo was chosen as primary end-point (visit 7). The<br /><br>rationale behind this is that 1) IL-10 is the key cytokine in the mechanism of<br /><br>SCIT [22, 23] and 2) the hypothesis is that IL-10 induction is more rapid in<br /><br>the presence of VD3 than without, hence visible already after 5 weeks of<br /><br>treatment. At 11 weeks the postulated difference may already not be as<br /><br>significant anymore.</p><br>

Secondary Outcome Measures