allergic rhinitis
Conditions
Interventions
Subcuteneous injections with
1. Purethal grasspollen per protocol
2. Calcitriol per protocol
3. Histamine (placebo for Purethal)
4. 0.9 % NaCl (placebo for Calcitriol).
Sponsors
Prof. dr. W.J. Fokkens, ENT surgeon
Department of Otorhinolaryngology,
Room A2-234, Academic Medical Center, Amsterdam
W.J.Fokkens@amc.nl
phone: +31 20 5663789
fax: +31 20 5669573
Eligibility
Inclusion criteria
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 ¡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.
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. 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. | — |
Contacts
Public ContactW.J. Fokkens
Academic Medical Center (AMC), Department of Otorhinolaryngology, Room A2-234, P.O. Box 22660
Outcome results
None listed