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Completed

NCT Number: NCT00227279

A Trial of the ALK Grass Tablet in Subjects With Hayfever

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

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Key information

Conditions

Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria:

  • A history of grass pollen induced rhinoconjunctivitis
  • Positive skin prick test to grass
  • Positive specific IgE to grass

Treatment and study plan

ALK Grass tablet

Biological

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

Primary outcomes

  1. Recording of rhinoconjunctivitis symptoms

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

  2. Recording of use of rescue medication

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

Secondary outcomes

  1. Quality of life

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

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study title

A Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Trial Assessing the Efficacy and Safety of ALK Grass Tablet in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 28, 2005
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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