Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422149
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2007-01-12
Brief Title:
Twin SUBLIVAC Grasses Clinical Efficacy Study
Sponsor:
HAL Allergy
Organization:
HAL Allergy
Study Overview
Official Title:
Twin SUBLIVAC Grasses Clinical Efficacy Study
Status:
COMPLETED
Status Verified Date:
2012-02
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:
To show that treatment with SUBLIVAC Grasses is clinically effective by means of reduction in allergic symptoms andor use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen
Detailed Description:
Indication under study IgE mediated allergic disorders triggered by grass pollen
Number of centres approximately 50
Study period planned Q2-2006 until Q3-2008 Analysis after one exposed season 2007 based on the outcome the study will be stopped or continued for another season
Subject selection criteria Seasonal rhinitis andor rhinoconjunctivitis with or without mild asthma FEV1 70 related to grass pollen age 12 years or older
Dosage schedule Start with two drops daily of SUBLIVAC and increase by two drops daily until the maintenance dose of 10 drops SUBLIVAC GrassesSUBLIVAC Grasses is reached
Route of administration Sublingual application drops are to be held underneath the tongue for 2-3 minutes and then will be swallowed
Duration of treatment 6 to 12 months blinded per subject Efficacy parameters
Number of centres approximately 50
Study period planned Q2-2006 until Q3-2008 Analysis after one exposed season 2007 based on the outcome the study will be stopped or continued for another season
Subject selection criteria Seasonal rhinitis andor rhinoconjunctivitis with or without mild asthma FEV1 70 related to grass pollen age 12 years or older
Dosage schedule Start with two drops daily of SUBLIVAC and increase by two drops daily until the maintenance dose of 10 drops SUBLIVAC GrassesSUBLIVAC Grasses is reached
Route of administration Sublingual application drops are to be held underneath the tongue for 2-3 minutes and then will be swallowed
Duration of treatment 6 to 12 months blinded per subject Efficacy parameters
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCTnr 2005-005175-16 | None | None | None |