Intraseasonal Short-time Up-dosing With Alutard SQ Grasses

Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807547
• Other study ID #: SHX0562
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2008
• Last updated: December 28, 2015
• Start date: April 2008
• Est. completion date: January 2009

Study information

• Verified date: December 2015
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: January 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Allergy

Intervention

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

Locations

Country	Name	City	State
Germany	Center for Rhinology and Allergology	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pfaar O, Wolf H, Klimek L, Schnitker J, Wüstenberg E. Immunologic effect and tolerability of intra-seasonal subcutaneous immunotherapy with an 8-day up-dosing schedule to 10,000 standardized quality-units: a double-blind, randomized, placebo-controlled tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in Immuno globuline E (IgE)-blocking factor		9 weeks	No
Secondary	Tolerability		9 weeks	Yes