A double blind randomized placebo controlled study on the efficacy of intralymphatic immunotherapy in the treatment of grasspollen induced allergic rhinitis.
- Conditions
- 10001708Allergic rhino-conjunctivitishayfever10046304
- Registration Number
- NL-OMON39544
- Lead Sponsor
- HagaZiekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Sensibilisation to grass pollen
age between 18 and 50 years old
Informed consent
No informed consent
instable or steroidtherapy dependent atopic astma
rhinosinusitis
nasal polyps
vasomotore rhinitis
immunosupressive medication
immuondeficiancy (IgG-IgA deficiaccy, HIV-AIDS)
pregnany or nursing
participation in other medical study
history of desensibilisation therapy
Significant cardiovascular disease
Severe impaired renal function
Hypersensitivity to aluminiumhydroxid
Childeren untill age of 18
Blood donation within previous 30 days
Surgery within the previous 30 days
Use of investigational drugs within previous 90 days
Mastocytosis
Hypertension
Active infectious disease
Significant hepatic disease
Significant renal disease
Significant hematological disorder
Significant pulmonary disease
Moderate or severe asthma
Autoimmune disease
History of malignancy.
Contraindicated medications were immunosuppressive agents, beta-blockers, ACE-inhibitors, and tricyclic antidepressants.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study outcome measure will be the level of allergic symptoms (VAS<br /><br>score) following intra nasal grass pollen provocation in patients treated with<br /><br>Alutard grass pollen compared with the results for patients treated with<br /><br>placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>changes in allergic skin prick test reactivity pre and post immunisation<br /><br>between the groups<br /><br>changes in serologic allergy tests pre and post immunisation between the groups<br /><br>changes in serum IgE and Ig4 levels pre and post immunisation between the groups<br /><br>changes in cellular infiltrates in the nasal mucosa pre and post immunisation<br /><br>between the groups</p><br>