Rhinitis, Allergic, Seasonal Clinical Trial
Official title:
Intralymphatic Immunotherapy in Increasing Doses up to 10 000 SQ-U - a Human Randomized Clinical Trial. Substudy.
The study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. Patients with allergy to grass or birch will be treated with three intralymphatic injections in an up-dosing protocol; 1000 SQ-U, 3000 SQ-U and 10 000 SQ-U, or placebo. ***IMPORTANT INFORMATION!*** The up-dosing protocol is changed due to adverse events at 5000 SQ-U. One patient had general utricaria 15 minutes after injection (moderate reaction). One patient had a serious adverse event with anaphylactic reaction 6 minutes after intralymphatic injection. (1000 SQ-U and 3000 SQ-U have been given with no serious adverse events.) New regimen: 1000 SQ-U, 3000 SQ-U, 3000 SQ-U.
40 patients with seasonal allergic rhinitis will be recruited. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses or birch. Injections are given with 4-5 (-7) weeks interval. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01337323 -
Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting
|
N/A | |
| Completed |
NCT00851344 -
Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo
|
Phase 2 | |
| Completed |
NCT00537355 -
An Evaluation of the Efficacy and Safety of TOLAMBA™ for Ragweed-Allergic Rhinitis in an Environmental Exposure Chamber
|
Phase 2 | |
| Completed |
NCT00501527 -
Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense
|
Phase 2 | |
| Completed |
NCT00422149 -
Twin SUBLIVAC® Grasses Clinical Efficacy Study
|
Phase 3 | |
| Completed |
NCT00542607 -
Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis
|
Phase 4 | |
| Completed |
NCT00605852 -
Investigation Of a New Oral Anti-Histamine in Healthy Male Subjects
|
Phase 1 | |
| Active, not recruiting |
NCT05960266 -
Immunological Analysis of Lymph Node Tissue After Intralymphatic Immunotherapy: A Prospective Case Control Study
|
Early Phase 1 | |
| Completed |
NCT02256553 -
Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006)
|
Phase 4 | |
| Completed |
NCT01007721 -
Randomized, Placebo Controlled, Crossover Study in an Environmental Challenge Chamber to Assess Safety & Efficacy of Three Oral Doses of BI 671800 Versus Fluticasone Propionate and Montelukast in Sensitive Seasonal Allergic Rhinitis Patients Out of Season
|
Phase 2 | |
| Completed |
NCT00932256 -
Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
|
Phase 1 | |
| Completed |
NCT00901914 -
Study of rBet v1 Tablets
|
Phase 2 | |
| Completed |
NCT00384475 -
A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)
|
Phase 3 | |
| Completed |
NCT00135629 -
Factors Predicting Efficacy of Allergen Injection Immunotherapy for Grass Pollen Hayfever
|
Phase 3 | |
| Completed |
NCT00839189 -
Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults
|
Phase 1 | |
| Completed |
NCT04687059 -
An Exploratory Study of PQ Grass 27600 SU
|
Phase 2/Phase 3 | |
| Completed |
NCT00889460 -
Safety and Tolerability Study of rBet v1 SLIT Tablets
|
Phase 1 | |
| Completed |
NCT00396149 -
Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1
|
Phase 1 | |
| Completed |
NCT00127647 -
An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)
|
Phase 3 | |
| Completed |
NCT00659594 -
Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray in Treatment of Seasonal Allergic Rhinitis (BY9010/M1-406)
|
Phase 3 |