Allergic Rhinitis Clinical Trial
Official title:
Intralymphatic Allergen-specific Immunity as a New Administration Route for Treatment of Pollen-induced Allergic Diseases
Verified date | August 2018 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Allergen-specific immunotherapy (ASIT) is commonly used to treat patients with allergic
rhino-conjunctivitis and asthma, and it is the only proven treatment that affects the
long-term development of allergic rhinitis and asthma. The current treatment regime of ASIT
requires numerous subcutaneous allergen injections and takes several years to complete.
Hence, there is a need to develop more convenient protocols for induction of allergen
tolerance.
Emerging evidence suggest that by targeting of antigen presenting cells within the lymph
nodes the immunogenicity of the allergen can be enhanced and the number of injections can be
reduced.
The purpose of this study is to evaluate whether intralymphatic administration of ASIT is a
safe and effective treatment for patients with pollen-induced allergic rhinitis. The long
term goal is to provide a base for a more efficient administration of ASIT, which will reduce
both the dose necessary and the number of clinic visits associated with the conventional
subcutaneous ASIT.
The investigators will make an attempt to reproduce the results of a recent human study of
intralymphatic ASIT (clinicaltrials.gov; NCT00470457) in a Swedish clinical setting.
The first part of the study is completed and published (PMID: 23374268)
Status | Completed |
Enrollment | 110 |
Est. completion date | December 2017 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Age 18-50, - Seasonal allergic symptoms for birch and/or grass verified by skin prick test, - Accepted informed consent Exclusion Criteria: - Pregnancy or nursing - Autoimmune or collagen disease (known) - Cardiovascular disease - Perennial pulmonary disease - Hepatic disease - Renal disease - Cancer - Any medication with a possible side-effect of interfering with the immune response - Previous immuno- or chemotherapy - Chronic diseases - Other upper airway disease (non-allergic sinusitis, nasal polyps, chronic obstructive and restrictive lung disease) - Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with ß-blockers) - Major metabolic disease - Known or suspected allergy to the study product - Alcohol or drug abuse - Mental incapability of coping with the study - Withdrawal of informed consent |
Country | Name | City | State |
---|---|---|---|
Sweden | Allergic Unit at the Department of Oto-Rhino-Laryngology at Skåne University Hospital Malmö | Malmö |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Karolinska University Hospital, Skane University Hospital |
Sweden,
Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wüthrich B, Crameri R, Graf N, Johansen P, Kündig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in subjective allergic symptoms following nasal allergen provocation | The study subjects will be intranasally challenged with allergen and symptom score questionnaires are filled out pre-provocation and 5, 10 and 30 min post-provocation. | Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. | |
Secondary | Registration of adverse event | from the first injection to 30 days after the last injections has been given | ||
Secondary | Effects on quality of life | SNOT-22 questionnaire | During peak pollen season which will be up to 5 months (birch) and 6 months (grass) after completed treatment | |
Secondary | Effects on quality of life | Juniper RQLQ questionnaires | During peak pollen season which will be up to 5 months (birch) and 6 months (grass) after completed treatment | |
Secondary | Change in medicine consumption during pollen season | After the pollen season patients report to what extension they have been using medications; more, the same or less. The mediacations asked about are antihistamine tablets, antihistamine eye drops, nasal steroid, steroid tablets, b2-bronchodilator inhalation, leucotrien receptor antagonist, nasal or ocular sodium chromoglycates. | 6-9 months after treatment. | |
Secondary | Change in symptoms at pollen season | After the pollen season at the 6-9 months follow up patients recall the pollen season and rates the improvement on an arbitrary scale ranging 0-10 with 0 as "no improvement at all" and 10 "total symptom relief". | 6-9 months after treatment. | |
Secondary | Short term improvement of skin reactivity | Skin prick test | Before treatment, an average of 4 weeks after completed treatment and 6-9 months after treatment. | |
Secondary | S-IgE Birch | Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment | ||
Secondary | S-IgE Grass | Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment | ||
Secondary | S-IgG4 Grass | Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment | ||
Secondary | S-IgG4 Birch | Before treatment, approximately 4 weeks after completed treatment and 6-9 months after treatment |
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