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Grass Pollen Subcutaneous Immunotherapy in Elderly Patients (SCITelderly)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02440243
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Information provided by (Responsible Party):
Andrzej Bozek, Medical University of Silesia

Brief Summary:

Background There is limited evidence indicating that specific immunotherapy in elderly patients is safe and effective. This study was performed to evaluate the safety and efficacy of specific subcutaneous immunotherapy (SCIT) against grass pollen allergens in patients over 60 years of age with seasonal allergic rhinitis (SAR) and a confirmed allergy to grass pollen.

Objective This study assessed the safety and efficacy of SCIT for grass pollen allergens in elderly patients with SAR.

Methods This study included 62 60- to 75-year-old patients with SAR and grass pollen allergy confirmed using a skin prick test, nasal provocation, and serum IgE measurement. The patients were individually randomized to the active or placebo groups using a double-blinded method. There were 33 subjects in the SCIT group (Purethal, Grass pollen, HAL Allergy B.V, Leiden, Netherlands) and 29 subjects in the placebo group monitored for three years. The patients were required to record each use of anti-allergy medication in a diary and use a visual graphic scale. The main outcome measure was the area under the curve (AUC) for the combined symptom and medication score (SMS).

Condition or disease Intervention/treatment Phase
Allergy Drug: Purethal Drug: Purethal -placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Grass Pollen Subcutaneous Immunotherapy: a Double-blind, Placebo-controlled Study in Elderly Patients With an Allergy to Grass Pollen
Study Start Date : January 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Patients active
Purethal Grass
Drug: Purethal
prerseasonal course of SCIT - three years
Other Name: Vaccine

Placebo Comparator: Patients placebo
Drug: Purethal -placebo
preseasonal course of SCIT - three years

Primary Outcome Measures :
  1. The symptoms reduction as a compsite measure [ Time Frame: three years ]
    The prime outcome measure was the area under the curve (AUC) for combined symptom and medication score (SMS)

  2. Evaluation of symptomatic medication use reduction [ Time Frame: three years ]
    Evaluation quantities of drugs based on patient diary.

Secondary Outcome Measures :
  1. Number of patients with a local allergic reaction after injections [ Time Frame: three years ]
    The local reactions were assessed at 30 min after injection and measured in cm.

  2. Number of patients with a systemic allergic reaction after injections [ Time Frame: three years ]
    The systemic reaction were assesed after injection according EAACI criteria.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE), and had positive nasal provocation tests (NPTs) with grass pollen mixture allergens

Exclusion Criteria:

  • hypersensitivity to other allergens, bronchial asthma, non-allergic rhinitis (especially senile or vasomotor rhinitis) and severe non-stable diseases.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Andrzej Bozek, Andrzej Bozek Assistant Professor, Director of Research, Medical University of Silesia Identifier: NCT02440243    
Other Study ID Numbers: MC56871/12
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs