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Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807547
First Posted: December 12, 2008
Last Update Posted: December 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ALK-Abelló A/S
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: 9 weeks ]

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
Biological: Allergy vaccination (Alutard SQ)
Alutard SQ grasses and rye, 8 subcutaneous injections, updosing to 10.000 SQ-U, duration of treatment 50 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 30, 2008
First Posted: December 12, 2008
Last Update Posted: December 29, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs