The efficacy of the combination of allergen vaccination and Vitamin D3 in the reduction of allergen-specific nasal responses. A placebo controlled trial.
- Conditions
- allergic rhinitis
- Registration Number
- NL-OMON28331
- Lead Sponsor
- Prof. dr. W.J. Fokkens, ENT surgeonDepartment of Otorhinolaryngology,Room A2-234, Academic Medical Center, AmsterdamW.J.Fokkens@amc.nlphone: +31 20 5663789fax: +31 20 5669573
- Brief Summary
Bousquet J, Lockey RF, Malling HJ. WHO Position Paper Allergen Immunotherapy: therapeutic vaccines for allergic diseases. Allergy 1998;53:44 Supplement.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
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 ¡Ý 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.
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 ƒÒ-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 (10x and 100x 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 during 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.