A study to determine the added value of vitamin D3 to treatment with subcutaneous immunotherapy in patients with birch pollen allergy

Phase 1

• Conditions: subcutaneous immunotherapy in allergic rhinitis (AR) patients with allergies to birchpollen; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2018-001339-33-NL
• Lead Sponsor: Academisch medisch centrum Amsterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-07
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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
7.A positive tNPT (for rules when a tNPT is positive see ref 40a)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
10.Active malignancies or any malignant disease during the previous 5 years.
11.Severe uncontrolled diseases that could increase the risk for patients participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders.
12.Active inflammation or infection of the target organs (nose, eyes or lower airways) at the start of the study.
13.Moderate to severe nasal obstructive diseases that preclude a TNPT (e.g., septal deviation, nasal polyps) or nasal/sinus surgery in the last 3 months.
14.Diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma).
15.Use of systemic steroids within 4 weeks before start of the study and during the study.
16.Treatment with systemic and local ß-blockers.
17.Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age (adequate contraceptive measures will be the use of a contraceptive device or oral contraceptive pill).
18.Alcohol, drug or medication abuse within the past year.
19.Any clinically significant abnormal laboratory parameter at screening.
20.Lack of cooperation or compliance.
21.Any physical or mental condition that precludes administration of SCIT, compliance or participation in a clinical trial.
22.Patients who are students or employees of the institution or 1st grade relatives or partners of the investigators
23.Participation in a clinical trial within 3 months prior to the current trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified