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OpenTrials
Completed

NCT Number: NCT00807547

Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

Test of pharmacodynamic efficacy and tolerability of a short-time intra-seasonal updosing

Completed

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Center for Rhinology and Allergology

Wiesbaden, D-65183, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • history of grass pollen induced allergic rhinoconjunctivitis
  • positive skin prick test

Exclusion criteria

  • uncontrolled severe bronchial asthma
  • previous treatment with immunotherapy within the previous 5 years
  • contraindication for specific immunotherapy

Treatment and study plan

Allergy vaccination (Alutard SQ)

Biological

Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days

Primary outcomes

  1. Changes from baseline in Immuno globuline E (IgE)-blocking factor

    Time frame: 9 weeks

Secondary outcomes

  1. Tolerability

    Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study title

A Randomised, Parallel-group, Double-blind, Placebo-controlled, Multicentre Phase III Trial Assessing the Pharmacodynamic Efficacy and Safety of an Intra-seasonal Short-time Updosing Schedule for Alutard SQ

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Dec 12, 2008
Registry last updated
Dec 29, 2015

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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