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Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00623701
Acronym
ALLEGRA6
Enrollment
126
Registered
2008-02-26
Start date
2008-03-31
Completion date
2012-10-31
Last updated
2013-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Conjunctivitis, Rhinitis

Keywords

sublingual grass pollen preparation, IgE-mediated Allergic Disease attributed to grass pollen

Brief summary

Efficacy and Safety from a high-dosed sublingual grass pollen preparation

Interventions

BIOLOGICALAllerslit forte

sublingual placebo preparation, daily

Sponsors

Allergopharma GmbH & Co. KG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Allergic rhinoconjunctivitis attributable to grass pollen * Positive SPT * Positive EAST * Positive provocation Test

Exclusion criteria

* Serious chronic disease * other perennial allergies

Design outcomes

Primary

MeasureTime frame
Symptom and Medication ScoreGrass pollen season 2009

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026