Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263601
Status:
COMPLETED
Last Update Posted:
2014-06-05
First Post:
2005-12-08
Brief Title:
Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis
Sponsor:
Allergopharma GmbH Co KG
Organization:
Allergopharma GmbH Co KG
Study Overview
Official Title:
A Multicentre Placebo Controlled Double-Blind Study for Evaluation of Safety and Efficacy of Preseasonal Specific Immunotherapy With an Allergoid Preparation of an Extract of a 6 Grass Pollen Mixture in Patients With Clinically Relevant Grass Pollen Sensitivity
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in Allergic Rhinoconjunctivitis
Detailed Description:
Pollen allergoids are prepared by chemical modification of partially purified native allergen aqueous extracts that have been depleted of components with a molecular mass of less than 5000 Daltons by diafiltration Clinical studies have shown a good tolerance of aqueous grass ragweed and tree pollen allergoids in comparison with allergen preparations Adsorption of pollen allergoids onto aluminium hydroxide suspensions results in depot preparations which have been investigated in a series of clinical studies and shown to be well tolerated with good clinical efficacy Depot pollen-allergoids were introduced into the German market in 1987 under the trade name Allergovit and are now firmly established and recommended primarily for shortcourse preseasonal immunotherapy in pollinosis Allergovit is currently available in many European and non-European countries A placebo-controlled study design was chosen as improvements in the symptoms of pollen allergies can not be shown over time as pollen seasons of different years are not comparable Due to the different mechanisms of action specific immunotherapy can not be compared with anti-allergic drugs Thus the only chance to prove efficacy for specific immunotherapy SIT is to test versus a parallel placebo group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None