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Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

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ClinicalTrials.gov Identifier: NCT00807547
Recruitment Status : Completed
First Posted : December 12, 2008
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

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

Condition or disease Intervention/treatment Phase
Allergy Biological: Allergy vaccination (Alutard SQ) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
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
Study Start Date : April 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Changes from baseline in Immuno globuline E (IgE)-blocking factor [ Time Frame: 9 weeks ]

Secondary Outcome Measures :
  1. Tolerability [ Time Frame: 9 weeks ]


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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

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

Publications of Results:
Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00807547     History of Changes
Other Study ID Numbers: SHX0562
First Posted: December 12, 2008    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015

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