Clinical Trials Logo
  1. Home
  2. Allergic Rhinoconjunctivitis
  3. NCT01740284

A Trial Evaluating Tolerability of Grazax Treatment in Combination With Antihistamine — GT-19  

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01740284
Study type Interventional
Source ALK-Abelló A/S
Contact
Status Completed
Phase Phase 3
Start date September 2008
Completion date January 2009
View Details
See also
  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 NCT01438463 - PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis Phase 2
Completed NCT01438827 - Avanz Phleum Pratense Maintenance Dose Phase 2/Phase 3
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