The efficacy of the combination of allergen vaccination and vitamin D3 in the reduction of allergen-specific nasal responses. A placebo controlled trial.

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 90

Inclusion Criteria

1. Patients with rhinoconjunctivitis with or without mild asthma for at least 2 years. Their allergic symptoms should be related to the grass-pollen season.
2. A positive skin prick test for grass, minimally HEP 1
3. Positive reaction to intranasal challenge with grass-pollen
4. Age between 18 and 65
5. Patients with a written informed consent

Note: Patients with concomitant sensitisation to perennial allergens like house dust mite and pets can be included as long as they do not reveal clinical symptoms or only at very rare occasional exposure. In case of sensitisation to pets, these pets should not be present at home.

Exclusion Criteria

1. Use of corticosteroids (systemic and local) outside grass-pollen season (May-July)
2. Serious immunopathologic diseases or malignancies (including auto-immune diseases, tuberculosis)
3. Severe asthma or emphysema, based on questionnaire; use of inhaled corticosteroids
4. Chronic symptoms related to concomitant sensitisation to other perennial allergens like pets or mites
5. Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension
6. Diseases with a contra-indication for the use of adrenaline
7. Severe kidney disease
8. Treatment with beta-blockers or ACE inhibitors or immunosuppressive drugs
9. Severe atopic dermatitis
10. Immunotherapy (including sublingual) treatment with grass-pollen within the last 5 years
11. Pregnancy, lactation or inadequate contraceptive measures
12 Alcohol or drug abuse
13. Lack of co-operation or severe psychological disorders

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early reduction of allergen induced inflammation (9 weeks) measured as symptoms of sneezing, rhinorrhoea and nasal blockage after an individually standardised allergen dose (10 x and 100 x the initial threshold provocation dose) in the first hour after each allergen provocation.

Secondary Outcome Measures

Name	Time	Method
1. Airway patency measured by PNIF during the first hour and the 24 hours after allergen challenge<br>2. Nasal symptom score for 24 hours after nasal allergen challenge<br>3. ECP/albumin ratio and cytokines (IL5, IL10) in nasal lavage<br>4. Clinical index score (CIS) during the grass-pollen season 2006

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