Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Trial of Immunological Outcomes of Sublingual Immunotherapy for House Dust Mite (D. Pteronyssinus) Allergy
Brief Summary: Allergic diseases represent a major health issue worldwide. Mainstay treatment is allergen avoidance and pharmacotherapy for symptom relief. Allergen immunotherapy offers the advantages of specific treatment with long lasting efficacy, and can modify the course of disease. However, use of this treatment is restricted by the high risk of adverse events especially in asthmatics. Other, better tolerated, routes of allergen administration than the current conventional subcutaneous route (SCIT) have been investigated including sublingual (SLIT). However, the immune parameters of SLIT have not been examined. We propose conducting a randomised, placebo-controlled study of a commercially-available SLIT for house dust mite (HDM) allergy to investigate induction of relevant T cell regulatory immune mechanisms. The first year will be followed by an optional open label extension period. Immunoregulatory cytokine synthesis and T cell phenotype and function (real time PCR and flow cytometry) will be examined. This project will provide important fundamental knowledge on which to base improved and greater application of this potentially curative treatment for allergy. SLIT has the potential advantage of home administration and suitability for patients with asthma who are currently unable to access many of the allergen desensitising regimens.


Options:
A: Inclusion Criteria:

* Allergic rhinitis
* Symptoms May-October
* Specific IgE to alternaria (skin test/radioallergosorbent \[RAST\] test)
* Age \>14

Exclusion Criteria:

* Sensitization to mites, parietaria, mugwort
* Pregnancy-lactation
* Malignancies
* Chronic systemic steroids
* Previous immunotherapy to alternaria
B: Inclusion Criteria:

1. Male or female outpatients aged 16 to 50 years (inclusive).
2. House dust mite-induced allergic asthma with or without perennial allergic rhinitis for at least 1 year.
3. Sensitised to D. pteronyssinus and D.farinae (positive skin prick test (SPT) with wheal diameter ≥ 4 mm and specific IgE level ≥ 0.70 kU/L
4. Patients treated with inhaled corticosteroids (ICS) before the screening visit at a dose ≥ 200 µg and \< 1,000 µg equivalent budesonide/day.

Exclusion Criteria:

1. Mild intermittent asthma needed to be treated only with β2-agonist (GINA level 1).
2. Severe asthma needed to be treated with inhaled corticosteroids with a dose ≥ 1,000 µg/day equivalent budesonide.
3. FEV1 \< 70% of predicted value at Visit 1.
4. Co-sensitisation to other inhalant allergens than dust mites leading to clinically relevant allergic asthma and proven by a positive skin prick test with wheal diameter ≥ 4 mm and serum specific IgE ≥ 0.70 KU/L .
5. Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of the study. These diseases include, but are not limited to, past or current cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease.
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:

* Positive RAST result to birch pollen
* Positive Skin Prick Test reaction to birch pollen
* positive nasal provocation test result to birch pollen extract

Exclusion Criteria:

* serious chronic diseases
* other relevant seasonal allergies

Answer: C