Allergic Rhinoconjunctivitis Clinical Trial
Official title:
A Phase III Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment
related adverse events when initiating treatment.
The majority are local allergic reactions within the mouth and/or throat, and most of these
reactions are mild or moderate. It is anticipated that intake of antihistamine before
initiation of Grazax treatment would most likely reduce the discomfort associated with
initiation of Grazax treatment. So this trial was to investigate if administration of
antihistamine prior to initiation of Grazax treatment results in a reduction of subjects
reporting local allergic reactions.
Many grass pollen allergic subjects treated with immunotherapy tablets experience treatment related adverse events when initiating treatment. The adverse events are considered consistent with the introduction of allergens in sensitised subjects. The majority are local allergic reactions within the mouth and/or throat. Most of these reactions are mild or moderate in intensity, have an onset almost immediately after taking a tablet, and last from minutes to hours after intake. Appearance of adverse events in relation to tablet intake tends to subside spontaneously within 1 to 7 days. Thus, initiation of treatment with Grazax may be associated with discomfort. It is anticipated that intake of antihistamine before initiation of Grazax treatment would most likely reduce the discomfort associated with initiation of Grazax treatment. Therefore, the rationale for this trial was to investigate if administration of antihistamine prior to initiation of Grazax treatment results in a reduction of subjects reporting local allergic reactions. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03850626 -
Validation of Combined Symptom Medication Score (cSMS) in Allergic Patients
|
||
Completed |
NCT03682965 -
Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
|
Phase 2 | |
Completed |
NCT04541004 -
Adolescent Mite Allergy Safety Evaluation
|
Phase 3 | |
Completed |
NCT02556801 -
Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy
|
Phase 2 | |
Completed |
NCT01918956 -
PURETHAL Birch RUSH Study
|
Phase 4 | |
Completed |
NCT01966224 -
A Safety and Immunogenicity Phase IB Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid Assessing the Long Term Safety of Previously Treated Subjects
|
Phase 1 | |
Completed |
NCT01682070 -
SUBLIVAC FIX Phleum Pratense DT/DRF
|
Phase 2 | |
Completed |
NCT01438827 -
Avanz Phleum Pratense Maintenance Dose
|
Phase 2/Phase 3 | |
Completed |
NCT01438463 -
PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis
|
Phase 2 | |
Completed |
NCT02437786 -
Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®
|
Phase 4 | |
Completed |
NCT00985296 -
Conjunctival Allergen Challenge (CAC) Following Allergen Exposure in the Allergen BioCube (ABC)
|
N/A | |
Completed |
NCT04912076 -
S.C. Immunotherapy With BM41 in Patients With Allergic Rhino-conjunctivitis Caused by Birch Pollen
|
Phase 1 | |
Completed |
NCT03365648 -
Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics
|
N/A | |
Completed |
NCT05455749 -
Effect of holoBLG on Cat Allergic Patients
|
N/A | |
Completed |
NCT01707069 -
A Safety and Immunogenicity Phase I Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid
|
Phase 1 | |
Completed |
NCT01466465 -
Vitamin D and Grass Pollen Specific Immunotherapy
|
Phase 2 | |
Completed |
NCT01567306 -
Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
|
Phase 2 | |
Completed |
NCT01490411 -
Dose Range Finding Study With rBet v1-FV - in Adult Patients With Birch Pollen-Allergic Seasonal Rhinoconjunctivitis
|
Phase 2 | |
Completed |
NCT00777374 -
Study of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects With Epicutanoeus Allergen Administration
|
Phase 2 | |
Active, not recruiting |
NCT04502966 -
Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction
|
Phase 2 |