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

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ClinicalTrials.gov Identifier: NCT00263601
Recruitment Status : Completed
First Posted : December 9, 2005
Last Update Posted : June 5, 2014
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG

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

Condition or disease Intervention/treatment Phase
Grass Pollen Allergy Biological: Allergovit 6-grasses Other: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre, Placebo Controlled, Double-Blind Study for Evaluation of Safety and Efficacy of Preseasonal Specific Immunotherapy With an Allergoid Preparation of an Extract of a 6 Grass Pollen Mixture in Patients With Clinically Relevant Grass Pollen Sensitivity
Study Start Date : November 2001
Primary Completion Date : May 2004
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Hay Fever
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Biological: Allergovit 6-grasses
Subcutaneous injections
Other Name: Specific immunotherapy with an allergoid preparation.
Placebo Comparator: 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.
Other: Placebo
Subcutaneous injections
Other Name: Comparator



Primary Outcome Measures :
  1. Symptom and Medication Score [ Time Frame: Assessment after the first and second grass pollen season. ]
    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).


Secondary Outcome Measures :
  1. Rhinoconjunctivitis Quality-of-Life Questionnaire [ Time Frame: First and second grass pollen season ]
    Changes in the scores of Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ by E Juniper) at baseline (outside the grass pollen season), every two weeks during the 3 months grass pollen season (year 1+2).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263601


Locations
Germany
Allergopharma GmbH & Co. KG
Reinbek, Germany, 21465
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
Investigators
Principal Investigator: Annemie Narkus, M.D.

Additional Information:
Publications:
Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00263601     History of Changes
Other Study ID Numbers: Al0101av
First Posted: December 9, 2005    Key Record Dates
Last Update Posted: June 5, 2014
Last Verified: June 2014

Keywords provided by Allergopharma GmbH & Co. KG:
Allergovit
Grass pollen allergy

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Hypersensitivity
Rhinitis, Allergic
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Immune System Diseases