Grass Pollen Subcutaneous Immunotherapy in Elderly Patients

NCT02440243 | Completed Phase 4

• 1 other identifier: MC56871/12
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Allergy

Outcome Measures

Primary Outcomes (2)

• The symptoms reduction as a compsite measure

  The prime outcome measure was the area under the curve (AUC) for combined symptom and medication score (SMS)

  three years

• Evaluation of symptomatic medication use reduction

  Evaluation quantities of drugs based on patient diary.

  three years

Secondary Outcomes (2)

• Number of patients with a local allergic reaction after injections

  three years

• Number of patients with a systemic allergic reaction after injections

  three years

Study Arms (2)

Patients active

ACTIVE COMPARATOR

Purethal Grass

Drug: Purethal

Patients placebo

PLACEBO COMPARATOR

Placebo

Drug: Purethal -placebo

Interventions

Purethal DRUG

prerseasonal course of SCIT - three years

Also known as: Vaccine

Patients active

Purethal -placebo DRUG

preseasonal course of SCIT - three years

Patients placebo

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• hypersensitivity to other allergens, bronchial asthma, non-allergic rhinitis (especially senile or vasomotor rhinitis) and severe non-stable diseases.

Sponsors & Collaborators

• Medical University of Silesia: lead

Related Publications (1)

• Bozek A, Kolodziejczyk K, Krajewska-Wojtys A, Jarzab J. Pre-seasonal, subcutaneous immunotherapy: a double-blinded, placebo-controlled study in elderly patients with an allergy to grass. Ann Allergy Asthma Immunol. 2016 Feb;116(2):156-61. doi: 10.1016/j.anai.2015.12.013.

  PMID: 26815709 DERIVED

MeSH Terms

Conditions

Hypersensitivity

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Andrzej Bozek Assistant Professor, Director of Research

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: May 12, 2015
• Study Start: January 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 12, 2015

Record last verified: 2015-05