Study to assess the clinical efficacy and safety of SUBLIVAC FIX Birch immunotherapy in patients with allergic rhinitis/rhinoconjunctivitis caused by birch polle
- Conditions
- Moderate to severe birch pollen induced allergic rhinitis/rhinoconjunctivitis with or without mild to moderate persistent asthma.MedDRA version: 18.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 100000004870Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2013-005550-30-CZ
- Lead Sponsor
- HAL Allergy B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
1. Signed informed consent
2. Age = 18 and =65 years
3. Moderate-to-severe birch pollen induced allergic rhinitis/rhinoconjunctivitis based on ARIA classification for at least 2 consecutive years24
4. FEV1 > 70% (of predicted value) for patients with a history of asthma, FEV1 > 70% or PEF > 80% (of predicted value) for patients without a history of asthma
5. Positive SPT for birch pollen (mean wheal diameter = 3mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter = 3mm)) assessed during screening.
6. Serum specific anti-birch IgE concentration >0.7 U/ml
Inclusion criteria to be assessed at Visit 2 before randomisation:
7. Patients should be willing and capable to complete an e-diary daily during the birch pollen season (= 60% compliance in completion between Visit 1 and 2).
8. A positive Nasal Provocation Test to birch pollen (per appendix 3) at Visit 2 (Lebel score = 6)25 or a documented positive test within 1 year before start of treatment
Inclusion criteria for Safety-Extension period:
1 Signed updated informed consent including Safety-Extension period
details
2 Patients that completed the double blind period of the study
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 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1. Patients sensitized and symptomatic to pets should not be included if they are regularly exposed to pets
2. Specific immunotherapy (SCIT or SLIT) with birch pollen or a cross-reacting allergen within the last 5 years
3. SPT positive (mean wheal diameter = 3mm compared to negative control; negative control should be negative; histamine control should be positive (mean wheal diameter = 3mm)) patients to allergen(s) other than birch pollen, in the absence of a negative provocation test for this allergen(s), who are expected to have clinically relevant symptoms during the birch pollen season
4. Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the last 5 years
5. (Ongoing) allergen-specific immunotherapy (SCIT or SLIT) with any allergen(s) during the study period
6. Vaccination one week before start of treatment and/or during the up-dosing phase
7. Treatment with experimental products within the last 3 months or biologicals (including anti-IgE or TNF- a treatment) within the last 6 months or during the study
8. Uncontrolled asthma or other active respiratory diseases
9. Clinically significant chronic sinusitis, ocular infection or severe inflammation of the oral mucosa
10. Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
11. Active malignancies or any malignant disease in the last 5 years
12. Acute or chronic disease that in the opinion of the investigator is an additional risk for the patients, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or haematological disorders
13. Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
14. Use of systemic corticosteroids 4 weeks before the study
15. Treatment with systemic or local ß-blockers
16. Known hypersensitivity to any of the excipients (Disodium phosphate dihydrate, Sodium dihydrogen phosphate dehydrate, Aminocaproic acid, Peppermint oil, Caramel Colorant or Glycerol)
17. A positive urine pregnancy test, lactation or inadequate contraceptive methods (adequate methods: oral contraceptives, IUD, condom use and having no sexual relationship with a man)
18. Alcohol-, drug or medication abuse
19. Lack of co-operation or compliance
20. Severe psychiatric, psychological, or neurological disorders
21. Any physical or mental condition that precludes administration or allergen-specific immunotherapy, compliance or participation in a clinical trial
22. Patients who are employees of the department, 1st grade relatives, or partners of the investigator
23. Patients who have planned holidays outside the country for more than 7 continuous days during the defined pollen season (1st of March till 31st of May)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method