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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014