Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01603056
Status:
COMPLETED
Last Update Posted:
2016-04-29
First Post:
2012-04-27
Brief Title:
Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis
Sponsor:
ALK-Abelló AS
Organization:
ALK-Abelló AS
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Phase III Multicentre Clinical Trial Investigating the Efficacy and Safety of Pangramin SLIT HDM-mix in Chinese Population With House Dust Mite Induced Rhinitis With or Without Asthma
Status:
COMPLETED
Status Verified Date:
2016-03
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:
Primary aim is to evaluate the efficacy of specific immunotherapy with Pangramin SLIT HDM-mix compared to placebo in the treatment of House Dust Mite HDM induced rhinitis with or without asthma
Sublingual immunotherapy has been used during several years and has been shown to provide benefits compare to traditional subcutaneous treatment This study will investigate if improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a consequence of being treated under specific immunotherapy
This study aim also to contribute to the documentation of tolerability and safety profile of Pangramin HDM Mix
Sublingual immunotherapy has been used during several years and has been shown to provide benefits compare to traditional subcutaneous treatment This study will investigate if improvements in rhinitis symptoms and less use of symptomatic medication can be obtained as a consequence of being treated under specific immunotherapy
This study aim also to contribute to the documentation of tolerability and safety profile of Pangramin HDM Mix
Detailed Description:
Extensive clinical experience has been gained due to the widespread use of Pangramin SLIT and other SLIT products as named patient products both with respect to the types and the frequencies of the adverse eventsAEs observed No safety concerns have been found
The optimal therapeutic dose range regarding SLIT is not fully elucidated The fate of the allergen after sublingual administration is not known in detail ie to what extent is the allergen absorbed over the mucosa or swallowed and how this is related to volume excipients etc The relationship between dose and effect is thus not fully elucidated The general recommendation is to use a dose inducing a clinical relevant effect in most patients without causing unacceptable adverse events As Pangramin SLIT HDM-mix has a safety profile that allows a single daily intake by the patient at home the dosage at this trial will be the same as marketed product
The optimal therapeutic dose range regarding SLIT is not fully elucidated The fate of the allergen after sublingual administration is not known in detail ie to what extent is the allergen absorbed over the mucosa or swallowed and how this is related to volume excipients etc The relationship between dose and effect is thus not fully elucidated The general recommendation is to use a dose inducing a clinical relevant effect in most patients without causing unacceptable adverse events As Pangramin SLIT HDM-mix has a safety profile that allows a single daily intake by the patient at home the dosage at this trial will be the same as marketed product
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