A Trial of the ALK Grass Tablet in Subjects With Hayfever

ALK-Abelló A/S634 enrolled

Overview

This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

634

Conditions

Allergy

Interventions

ALK Grass tabletBIOLOGICAL

Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Eligibility Criteria: * A history of grass pollen induced rhinoconjunctivitis * Positive skin prick test to grass * Positive specific IgE to grass

Locations (1)

Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital

Aarhus C, Denmark

Outcomes

Primary Outcomes

Recording of rhinoconjunctivitis symptoms

Time frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009

Recording of use of rescue medication

Time frame: Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009

Secondary Outcomes

Quality of life

Time frame: Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009

Data from ClinicalTrials.gov

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