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Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00807547
First received: September 30, 2008
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Allergy
 Biological: Allergy vaccination (Alutard SQ)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Changes from baseline in Immuno globuline E (IgE)-blocking factor [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 149
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Allergy vaccination
Allergy vaccination by 6 subcutaneous injections to 10,000 SQ-U with 1-3 days intervals, continuation by 2 injections with 10,000 SQ-U with 2-4 weeks intervals
 Biological: Allergy vaccination (Alutard SQ)
Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days
Placebo Comparator: Subcutaneous injections
Placebo injections

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807547

Locations
Germany
Center for Rhinology and Allergology
Wiesbaden, Germany, D-65183
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
Principal Investigator: Ludger Klimek, MD Center for Rhinology and Allergology, An den Quellen 10, 65183 Wiesbaden, Germany
  More Information

Publications:

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00807547     History of Changes
Other Study ID Numbers: SHX0562
Study First Received: September 30, 2008
Last Updated: February 8, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on June 17, 2013