Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation
ALLEGRA6
A Multicentre, Multinational, Placebo-controlled, Double-blind, Randomized Study to Evaluate Efficacy and Safety of a Perennial, Sublingual, Specific Immunotherapy in Patients With Rhinoconjunctivitis With/Without Controlled Asthma Caused by Grass Pollen
2 other identifiers
interventional
126
1 country
1
Brief Summary
Efficacy and Safety from a high-dosed sublingual grass pollen preparation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2008
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2008
CompletedFirst Posted
Study publicly available on registry
February 26, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 8, 2013
November 1, 2013
3.6 years
February 19, 2008
November 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Symptom and Medication Score
Grass pollen season 2009
Study Arms (2)
1
PLACEBO COMPARATORsublingual placebo preparation
2
EXPERIMENTALSublingual preparation, 40 micro grams Phl p 5 maintenance dose
Interventions
Eligibility Criteria
You may qualify if:
- Allergic rhinoconjunctivitis attributable to grass pollen
- Positive SPT
- Positive EAST
- Positive provocation Test
You may not qualify if:
- Serious chronic disease
- other perennial allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prof. Kristian Reich, MD
Hamburg, 20354, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristian Reich, Professor
not affiliated
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2008
First Posted
February 26, 2008
Study Start
March 1, 2008
Primary Completion
October 1, 2011
Study Completion
October 1, 2012
Last Updated
November 8, 2013
Record last verified: 2013-11