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


- candidate number1843
- NTR NumberNTR522
- ISRCTNISRCTN42318360
- Date ISRCTN created9-jan-2006
- date ISRCTN requested13-dec-2005
- Date Registered NTR21-nov-2005
- Secondary IDsPG/0020 (MEC 05/204) 
- Public TitleThe efficacy of the combination of allergen vaccination and Vitamin D3 in the reduction of allergen-specific nasal responses. A placebo controlled trial.
- Scientific TitleThe efficacy of the combination of allergen vaccination and Vitamin D3 in the reduction of allergen-specific nasal responses. A placebo controlled trial.
- ACRONYMVITAL
- hypothesisAddition of subcutaneous vitamin D3 to subcutaneous allergen vaccination offers a superior protection to allergen-induced inflammation and obstruction, in comparison to allergen vaccination alone.
- Healt Condition(s) or Problem(s) studiedRhinitis
- Inclusion criteria1. 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 criteria1. 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 -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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-dec-2005
- planned closingdate31-dec-2006
- Target number of participants90
- InterventionsSubcuteneous injections with 1. Purethal grasspollen per protocol; 2. Calcitriol per protocol; 3. Histamine (placebo for Purethal); 4. 0.9 % NaCl (placebo for Calcitriol).
- Primary outcomeEarly 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 outcome1. Airway patency measured by PNIF during the first hour and the 24 hours after allergen challenge; 2. Nasal symptom score during 24 hours after nasal allergen challenge; 3. ECP/albumin ratio and cytokines (IL5, IL10) in nasal lavage; 4. Clinical index score (CIS) during the grass-pollen season 2006.
- Timepoints
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. W.J. Fokkens
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W.J. Fokkens
- Sponsor/Initiator Academic Medical Center (AMC), Department of Otorhinolaryngology
- Funding
(Source(s) of Monetary or Material Support)
HALMON Laboratoria Beheer B.V., MedAmon B.V. i.o.
- PublicationsBousquet J, Lockey RF, Malling HJ. WHO Position Paper Allergen Immunotherapy: therapeutic vaccines for allergic diseases. Allergy 1998;53:44 Supplement.
- Brief summaryAllergen vaccination or immunotherapy (IT) was proven to be effective in the following respects: 1. Reduction of symptoms in patients with allergic rhinitis 2. Reduction of symptoms in patients with allergic asthma 3. Reduction of bronchial hyperreactivity in patients with asthma 4. Prophylaxis of the occurrence of asthma in predisposed patients with allergy However, large scale use of allergen vaccination in patients with allergic airway inflammation (rhinitis/asthma) is hampered by the following considerations: Long duration of treatment (time to maximal effect >6 months) Risks associated with anaphylactic and broncho-obstructive side effects Discomfort of the treatment (vaccination) Inability to distinguish responders from non-responders in advance Improvements in allergen vaccination/ immunotherapy should therefore aim at increasing effect/side effect ratios and decreasing discomfort and duration of treatment. Recent evidence in mouse models of allergic asthma suggests that the effect of allergen vaccination on bronchial hyperresponsiveness can be markedly increased by combining allergen vaccination with the addition of vitamin D3 Allergen vaccination and vitamin D3 are both registered prescriptions in man, which would allow us to test whether similar effects can be observed in human allergic disease. As testing clinical effects of allergic disease requires inclusion of many patients due to the broad scope of and relative poor reproducibility of individual effects, it would be more practical to focus firstly on the two most important mechanisms influenced by the intervention. These are the anti-inflammatory effect and the reduction of nasal obstruction. Therefore we propose a test design aiming at supplying the following proof of concept: Combination of allergen vaccination and Vitamin D3 offers a superior protection to allergen-induced inflammation and obstruction, in comparison to allergen vaccination alone. This hypothesis will be tested first in patients with allergic rhinitis as the nose is best accessible for direct measurements of inflammation.
- Main changes (audit trail)
- RECORD21-nov-2005 - 2-sep-2009


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