Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture

Grass Pollen Allergy Clinical Trial

Official title:

A Multicentre, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of a Perennial Sublingual Specific Immunotherapy With a Liquid Formulation of an Extract of a Six Grass Pollen-mixture in Patients With Clinically Relevant Grass Pollen Sensitivity.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264459
• Other study ID #: Al0102st
• Status: Completed
• Phase: Phase 3
• First received: December 12, 2005
• Last updated: January 23, 2014
• Start date: February 2003
• Est. completion date: September 2011

Study information

• Verified date: January 2014
• Source: Allergopharma GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2011
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Rhinitis, Rhinoconjunctivitis, Positive Rast result to grass pollen, Positive skin prick test to grass pollen, Positive specific provocation to grass pollen,

Exclusion Criteria:

Serious chronic diseases, Other perennial allergies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Grass Pollen Allergy
• Hypersensitivity
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• Grass pollen formulation
Solution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.

Other:
• Comparator
Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.

Locations

Country	Name	City	State
Germany	Allergopharma GmbH & Co. KG	Reinbek

Sponsors (1)

Lead Sponsor	Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Pfaar O, Klimek L. Efficacy and safety of specific immunotherapy with a high-dose sublingual grass pollen preparation: a double-blind, placebo-controlled trial. Ann Allergy Asthma Immunol. 2008 Mar;100(3):256-63. — View Citation

Worm M. Efficacy and tolerability of high dose sublingual immunotherapy in patients with rhinoconjunctivitis. Eur Ann Allergy Clin Immunol. 2006 Dec;38(10):355-60. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom and Medication Score (SMS)	The primary endpoint is the change of the area under the curve (AUC, derived from an analysis period of 42 days) of the daily sum of the Symptom and Medication Score (SMS) from the baseline measurement to the measurement after 1.5 years of therapy.	1.5 years of therapy	No
Secondary	Visual Rating Scale	Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)	1.5 years	No

External Links

•   Leader in specific allergy research and therapy