Ignite Creation Date:
2024-05-05 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00550875
Status:
COMPLETED
Last Update Posted:
2011-07-13
First Post:
2007-08-22
Brief Title:
Efficacy-safety Study of Sublingual Immunotherapy With Depigmented-polymerized Pollen Extracts to Treat Rhinoconjunctivitis
Sponsor:
Laboratorios Leti SL
Organization:
Laboratorios Leti SL
Study Overview
Official Title:
A Randomised Double Blind Placebo Controlled Study to Evaluate the Efficacy and Safety of Sublingual Immunotherapy With a Depigmented and Polymerized Grass Pollen Extracts in Patients Suffering From Allergic Rhinoconjunctivitis
Status:
COMPLETED
Status Verified Date:
2011-07
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:
GPIT
Brief Summary:
As the principal objective of this study is to evaluate the efficacy and safety of the treatment measuring the changes in a symptom score the patient will be asked to fill in a patient diary This diary will evaluate the week before the patient comes back to receive the treatment Nose sneeze blockage and running eye itching redness and swelling and chest breathlessness wheeze chest tightness are scored on a scale from The patient will be instructed to daily assess each one of the symptoms recording them on an individual symptoms follow-up diary
Detailed Description:
The study drug is a sublingual immunotherapy vaccine with allergenic extract of grass pollen Lolium perenne 50 Cynodon dactylon 50 Sublingual immunotherapy has been available on the European market to treat patients with allergic rhinoconjunctivitis itching sneezing stuffy nose runny nose for many years In this study it will be used as drops under the tongue At the beginning of the study you will be given a card that documents that you are taking part Please carry this with you at all times in case treatment is necessary at another location The drops will be given at two doses The drops are held under the tongue for 2 minutes prior to swallowingSublingual Immunotherapy has been shown to be safe and effective in reducing the symptoms of allergic rhinoconjunctivitis nasal allergy and allergy of the eyes
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