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

NCT00264459 | Completed Phase 3

• 1 other identifier: Al0102st
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Grass Pollen Allergy

Keywords

Sublingual immunotherapy; Rhinoconjunctivitis; Rhinitis; Asthma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Visual Rating Scale

  1.5 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo was given the same way as a sublingual preparation.

Other: Comparator

Liquid formulation of an extract of a 6 grass pollen mixture

EXPERIMENTAL

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

Interventions

Grass pollen formulation BIOLOGICAL

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.

Also known as: specific immunotherapy

Liquid formulation of an extract of a 6 grass pollen mixture

Comparator OTHER

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

Also known as: Specific Immunotherapy

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Serious chronic diseases, Other perennial allergies

Sponsors & Collaborators

• Allergopharma GmbH & Co. KG: lead

Study Sites (1)

Allergopharma GmbH & Co. KG

Reinbek, 21465, Germany

Location

Related Publications (2)

• 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.

  PMID: 17274520 RESULT

• 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. doi: 10.1016/s1081-1206(10)60451-6.

  PMID: 18426146 RESULT

Related Links

• Leader in specific allergy research and therapy

MeSH Terms

Conditions

Rhinitis; Asthma

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Ludger Klimek, M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 13, 2005
• Study Start: February 1, 2003
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2011
• Last Updated: January 24, 2014

Record last verified: 2014-01

Locations

DE (1)