Study to determine the safety/tolerability of the simultaneous treatment of BM41-vaccine and vitamin D 3 in patients with birch pollen allergy.

Phase 1

• Conditions: moderate to severe allergic rhinitis/rhino-conjunctivitis caused by birch pollen (with or without concomitant mild to moderate persistent asthma); Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-004827-22-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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) 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 TNPT for birch pollen at screening (Lebel score =6)

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 160
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