Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-31 @ 8:42 PM
Study NCT ID:
NCT01634958
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2012-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma
Sponsor:
Leti Pharma GmbH
Organization:
Study Overview
Official Title:
A Randomised, Double-Blind, Parallel Group, Multicentre Study to Assess the Efficacy and Safety of Four Concentrations of Depigoid® Phleum in Patients With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma
Status:
COMPLETED
Status Verified Date:
2013-11
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:
Specific immunotherapy for IgE mediated sensitization to grass pollen
4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the optimum dose.
4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the optimum dose.
Detailed Description:
This is a dose finding study and no therapeutic study. Patients will receive in 4-weekly intervals 6x 0,5mL of one of 4 different concentrations of Depigoid Phleum. The study is performed outside the pollen season. Thus the aim of the study is not the therapeutic effect of the specific immunotherapy (effect on allergy specific symptoms during the pollen season) but the effect on the Conjunctival provocation test (CPT). According to the EMA "Guideline on clinical development of products for specific immunotherapy for the treatment of allergic diseases" provocation tests are accepted as primary outcomes for dose-finding studies.
For the CPT increasing doses of Phleum pollen solutions are applied to the eye and characteristic symptoms (eye redness, weeping, itching or burning, and nose dripping/blockage) are assessed at each concentration: 0=absent, 1=mild, 2=moderate, 3=severe. At a score value of \>=5/concentration the test is considered positive and finished.
It is expected that at the end of the study higher doses are necessary to provoke a positive CPT.
Furthermore comparative evaluation of the safety data (AEs) in the different dosage groups is a very important parameter for the evaluation of the outcome of the study.
For the CPT increasing doses of Phleum pollen solutions are applied to the eye and characteristic symptoms (eye redness, weeping, itching or burning, and nose dripping/blockage) are assessed at each concentration: 0=absent, 1=mild, 2=moderate, 3=severe. At a score value of \>=5/concentration the test is considered positive and finished.
It is expected that at the end of the study higher doses are necessary to provoke a positive CPT.
Furthermore comparative evaluation of the safety data (AEs) in the different dosage groups is a very important parameter for the evaluation of the outcome of the study.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-000416-28 | EUDRACT_NUMBER | None | View |