Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis

NCT ID: NCT00263601

Last Updated: 2014-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2010-08-31

Brief Summary

The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in Allergic Rhinoconjunctivitis

Detailed Description

Pollen allergoids are prepared by chemical modification of partially purified native allergen aqueous extracts that have been depleted of components with a molecular mass of less than 5000 Daltons by diafiltration. Clinical studies have shown a good tolerance of aqueous grass, ragweed and tree pollen allergoids in comparison with allergen preparations. Adsorption of pollen allergoids onto aluminium hydroxide suspensions results in depot preparations which have been investigated in a series of clinical studies and shown to be well tolerated with good clinical efficacy. Depot pollen-allergoids were introduced into the German market in 1987 under the trade name Allergovit® and are now firmly established and recommended primarily for shortcourse preseasonal immunotherapy in pollinosis. Allergovit® is currently available in many European and non-European countries. A placebo-controlled study design was chosen as improvements in the symptoms of pollen allergies can not be shown over time, as pollen seasons of different years are not comparable. Due to the different mechanisms of action, specific immunotherapy can not be compared with anti-allergic drugs. Thus the only chance to prove efficacy for specific immunotherapy (SIT) is to test versus a parallel placebo group.

Conditions

Grass Pollen Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Allergovit 6-grasses immunotherapy

Seven injections (with 7 to 14 day intervals between each one) to reach maximum dose, followed by maintenance injections starting with 2 week intervals, followed by 4 week intervals until onset of the grass pollen season.

Group Type: EXPERIMENTAL

Allergovit 6-grasses

Intervention Type: BIOLOGICAL

Subcutaneous injections

Placebo

Placebo injections was given the same way: Seven injections (with 7 to 14 day intervals between each one) to reach maximum dose, followed by maintenance injections starting with 2 week intervals, followed by 4 week intervals until onset of the grass pollen season.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Subcutaneous injections

Interventions

Allergovit 6-grasses

Subcutaneous injections

Intervention Type: BIOLOGICAL

Placebo

Subcutaneous injections

Intervention Type: OTHER

Other Intervention Names

Specific immunotherapy with an allergoid preparation.; Comparator

Eligibility Criteria

Inclusion Criteria

• Positive Skin Prick test to grass pollen
• Positive RAST to grass pollen
• Positive specific provocation test to grass pollen

Exclusion Criteria

• Serious chronic diseases
• Other perennial allergies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergopharma GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annemie Narkus, M.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

Allergopharma GmbH & Co. KG

Reinbek, , Germany

Countries

Germany

References

Corrigan CJ, Kettner J, Doemer C, Cromwell O, Narkus A; Study Group. Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid. Allergy. 2005 Jun;60(6):801-7. doi: 10.1111/j.1398-9995.2005.00790.x.

Reference Type: RESULT

PMID: 15876311 (View on PubMed)

Williams A, Henzgen M, Rajakulasingam K. Additional benefit of a third year of specific grass pollen allergoid immunotherapy in patients with seasonal allergic rhinitis. Eur Ann Allergy Clin Immunol. 2007 Apr;39(4):123-6.

Reference Type: RESULT

PMID: 17523386 (View on PubMed)

Related Links

http://www.allergopharma.de

Leader in specific allergy research and therapy

Other Identifiers

Al0101av

Identifier Type: -

Identifier Source: org_study_id