Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Multi-national, Phase IIIb Study to Assess the Sustained Clinical Effect and Safety of Sublingual Immunotherapy Administered as Birch Pollen Extract Solution at a Dose of 300 IR Once Daily to Patients Suffering From Birch Pollen-induced Rhinoconjunctivitis
Brief Summary: The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.


Options:
A: Inclusion Criteria:

1. Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
2. Positive SPT to grasses
3. Total symptoms score for the previous pollen season more than 12 out of 18.
4. Patients with FEV1 ≥ 80% of the predicted value.

Exclusion Criteria:

1. Positive SPT to other grasses present during the grass pollen season and if endemic to the region
2. Patients with clinically significant confounding symptoms of allergy to other allergens potentially overlapping the grass pollen season
3. Asthma requiring treatment with medications other than beta-2 inhaled agonists.
4. Patients who have received any desensitization treatment for grass pollen in the past 5 years.
5. Ongoing immunotherapy with any other allergen.
6. Patients with any nasal or oral condition that could confound the efficacy or safety assessments
7. Patients with known history of hypersensitivity or intolerance to any of the excipients in the investigational product (such as lactose intolerance).
8. Patients with any past or current clinically significant condition which as judged by the investigator, may affect the patient's participation or the outcome of the study.
9. Patients treated with systemic or inhaled corticosteroids
10. Patients treated or under treatment with beta-blockers, continuous systemic corticotherapy or immunosuppressive drugs.
11. Pregnant, breastfeeding, or sexually active women who are not using a medically accepted contraceptive method as listed above.
12. Patients participating or having participated within 30 days before Screening in any clinical study.
13. Patients who are unlikely to complete the study for any reason, or patients who have to travel for extended periods of time during the grass pollen season which will compromise the data
14. Patients with history of drug or alcohol abuse.
15. Study staff, investigators, sub-investigators, as well as their children or spouses and family members of all study staff should not be enrolled in the study.
16. Patients will not be randomized in this study more than once.
B: Inclusion Criteria:

* Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the previous 2 pollen seasons requiring intake of symptomatic treatment.
* Sensitization to birch pollen demonstrated by a positive Skin Prick Test to birch pollen with wheal diameter \> 3 mm and birch pollen allergens specific IgE levels ≥ 0.70 kU/L.
* RRTSS based on the previous or on the penultimate birch pollen season ≥ 12 out of a maximum possible score of 18.
* Patients with an FEV1 (Forced Expiratory Volume at one second) ≥ 80% of the predicted value.
* Patients who are willing to comply with the protocol.
* Patients having given a signed informed consent before completing any study related procedure.

Exclusion Criteria:

* Patients with symptoms of rhinitis/rhinoconjunctivitis during the birch pollen season due to any other allergens (except alder and hazel). This includes patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study.
* Patient who previously received desensitization treatment to birch pollen and/or another Betulaceae sp. (for example hazel or alder) within the previous 5 years.
* Patients with ongoing treatment by immunotherapy with another allergen.
* Pregnancy (positive pregnancy test), breast-feeding.
* Female patients of childbearing potential planning a pregnancy during this study or not using a medically accepted contraceptive method (hormonal birth control \[orally, injectable or by implant, for at least 2 months before enrolment\], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner).
* Patients planning to move during the study or planning to leave the area during the birch pollen season for more than 1 week (7 consecutive days).
* Patients with moderate or severe persistent asthma (GINA 3 or 4).
* Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents.
* Patients with any nasal or oral condition that could interfere with the efficacy or safety assessments (such as nasal polyposis or oral inflammation).
* Patients with severe immune deficiency.
* Patients with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or outcome of this study.
* Any other disease or condition which would place a patient at undue risk by being included in the study (according to the Investigator's opinion).
* Usual contra-indications of immunotherapy such as concomitant beta-blocker therapy whatever the route and/or immunosuppressive drugs.
* Patients treated with inhaled/systemic steroids (whatever the indication) within 4 weeks prior to Visit 1 (Screening), or with long acting systemic corticosteroids 12 weeks before Visit 1 (Screening).
* Patients under continuous corticotherapy (inhaled or systemic drugs).
* Patients following a strict low sodium diet as the study treatment contains 590 mg of sodium chloride per vial in a 10 mL solution.
* Investigators, co-Investigators, as well as their children or spouses and all study collaborators.
C: Inclusion Criteria:

* allergic rhinitis and/or
* mild stable asthma
* house dust mite allergic
* positive HDM-specific IgE as determined by skin prick test (wheal diameter \>6 mm to D. pteronyssinus) or CAP-Pharmacia score \> 2

Exclusion Criteria:

* Immunodeficiency diseases
* Severe or uncontrolled asthma
* Previous immunotherapy with House dust mite (HDM) extract within the last five years or ongoing immunotherapy with HDM or other allergens
* Continuous oral corticosteroids
* Subjects on treatment with beta-blockers
* Pregnant women
D: Inclusion Criteria:

* A history of house dust mite induced asthma
* Use of inhaled corticosteroids (ICS)
* Positive skin prick test to house dust mites
* Positive specific IgE to house dust mites

Exclusion Criteria:

* FEV1 lower than 70%

Answer: B