A randomized, double-blind, placebo-controlled, double-dummy study to determine the safety/tolerability of a simultaneous subcutaneous treatment of BM41 and vitamin D3 in patients with moderate to severe allergic rhinitis/ rhinoconjunctivitis caused by birch pollen.
- Conditions
- allergic rhinitisbirchpollen allergy10046304
- Registration Number
- NL-OMON45256
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 40
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 TNPT for birch pollen at screening (Lebel score *6)
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 *-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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the number of treatment-related systemic reactions<br /><br>(classified in accordance with the WAO-grading system) in the BM41/VD3<br /><br>treatment group compared to BM41/Placebo2, VD3/Placebo1 and Placebo1/Placebo2<br /><br>throughout the pre-seasonal treatment course. This will be determined at every<br /><br>visit according to the reports of the patient. </p><br>
- Secondary Outcome Measures
Name Time Method