Safety and Efficacy of a Sublingual Specific Immunotherapy With an Extract of a Six Grass Pollen Mixture - Full Text View

Purpose

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

Condition	Intervention	Phase
Grass Pollen Allergy	Biological: Grass pollen formulation Other: Comparator	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever

U.S. FDA Resources

Further study details as provided by Allergopharma GmbH & Co. KG:

Primary Outcome Measures:

Symptom and Medication Score (SMS) [ Time Frame: 1.5 years of therapy ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Visual Rating Scale [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)

Enrollment:	160
Study Start Date:	February 2003
Study Completion Date:	September 2011
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo was given the same way as a sublingual preparation.	Other: Comparator Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter. Other Name: Specific Immunotherapy
Experimental: Liquid formulation of an extract of a 6 grass pollen mixture 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. Initial treatment was applied on the first day of treatment with a starting dose of 25% of the maintenance dose. Increasing doses of 50% were applied with the second and 100% with the third dose to give the maximum (=maintenance) dose. This was followed by a daily patient selfadministered treatment with the maintenance dose.	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 Name: specific immunotherapy

Arms

Assigned Interventions

Placebo Comparator: Placebo

Placebo was given the same way as a sublingual preparation.

Other: Comparator

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

Other Name: Specific Immunotherapy

Experimental: Liquid formulation of an extract of a 6 grass pollen mixture

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. Initial treatment was applied on the first day of treatment with a starting dose of 25% of the maintenance dose. Increasing doses of 50% were applied with the second and 100% with the third dose to give the maximum (=maintenance) dose. This was followed by a daily patient selfadministered treatment with the maintenance dose.

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 Name: specific immunotherapy

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00264459

Locations

Germany
Allergopharma GmbH & Co. KG
Reinbek, Germany, 21465

Sponsors and Collaborators

Allergopharma GmbH & Co. KG

Investigators

Principal Investigator:

Ludger Klimek, M.D.

More Information

Additional Information:

Leader in specific allergy research and therapy This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:	NCT00264459 History of Changes
Other Study ID Numbers:	Al0102st
Study First Received:	December 12, 2005
Last Updated:	March 8, 2013
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Allergopharma GmbH & Co. KG:

Sublingual immunotherapy
Rhinoconjunctivitis
Rhinitis
Asthma

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Hypersensitivity
Rhinitis
Nose Diseases
Respiratory Tract Diseases

Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013