Revaccination With Pollinex® Quattro

December 19, 2023 updated by: Prof. Dr. Ralph Mösges

Non-interventional Study A Multicentre Observational Study for Revaccination With Pollinex® Quattro in Patients With a Recurrent Grass Pollen Allergy

The purpose of this non interventional study (NIS) was to observe the efficacy of Pollinex® Quattro as a short-term revaccination in patients who have already been successfully desensitized at least five years ago against grass-pollen but developed a recurrent allergy.

Study Overview

Status

Completed

Conditions

Detailed Description

The increasing prevalence of allergies represents a major problem for the health care system. Approximately 500 million people are suffering worldwide from allergic rhinitis (AR). Allergic rhinitis is a Type 1 hypersensitive disorder, initiated by IgE antibodies. Whereas seasonal allergic rhinitis (SAR) is caused by different allergens found outdoors such as grass, tree and weed pollen, perennial allergic rhinitis (PAR) is caused by allergens that are mainly found indoors such as dust mites, mould or animal hair.

Specific immunotherapy (SIT) presently constitutes the only causal therapy available and is common practice. SIT is indicated in cases of IgE-mediated allergic diseases and includes two forms of treatment options: subcutaneous (SCIT) and sublingual immunotherapy (SLIT). Both therapies aim to train the immune system not react to supposed pathological allergens, but instead to develop tolerance to them.

Even though allergy vaccinations have been applied for a century, the commonly used SCIT requires up to 90 injections over three to five years. Pollinex® Quattro is currently the only ultra-short term medicinal product which requires only four preseasonal injections. The immunological effect associated with Pollinex® Quattro shows an increase of allergen-specific IgG antibodies and a decrease of allergen-specific IgE antibodies as well as a shift from a Th2 to a more Th1 type-immune reaction. Previous studies on the therapeutic efficacy of Pollinex® Quattro have come to a positive conclusion in regards to tolerability and decrease of allergic symptoms. As an ultra-short course SCIT, Pollinex® Quattro might decrease the number of noncompliance and withdrawal for revaccination in patients that have already undergone an intensive immunisation therapy.

In this non-interventional study, patients who were treated with Pollinex® Quattro and patients who decided to use anti-allergic drugs for the treatment of their grass pollen allergy were compared due to their allergic symptoms in the grass pollen season from May to July. For this purpose, the rhinoconjunctivitis and asthmatic symptoms as well as the use of concomitant medication were documented in a dia

Study Type

Observational

Enrollment (Actual)

108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen.

Description

Inclusion Criteria:

  • Adults and children from the age of 12 years on, who are diagnosed with recurrent seasonal allergic rhinitis (SAR) caused by grass pollen.

A previous specific immunotherapy finished at least five years ago had to be successful.

Exclusion Criteria:

  • Contraindications according to the patient information leaflet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group 1: Pollinex® Quattro Patients
Patients treated with Pollinex® Quattro
Group 2: Control Patients
Patients who decided to use only anti-allergic drugs during the grass pollen season

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the efficacy of Pollinex® Quattro based on the Combined Symptom and Medication Score (CSMS) (Pfaar et al., 2014).
Time Frame: 3 months

The CSMS consists of the six individual rhinoconjunctivitis scores for sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes, the asthma scores for cough, breathlessness, wheeze and tightness in the chest as well as the score for the use of concomitant medication (oral antihistamines, nasal corticosteroids, oral corticosteroids, asthma inhalation spray). The symptoms and the use of drugs were documented in a diary: The symptom score was:

0=none, 1=mild, 2=moderate, 3=severe. Evaluation will be done for the peak of the grass pollen season, defined by those 30 consecutive days per center with the highest local grass pollen counts (according to Deutscher Wetterdienst Medizin-Meteorologie, http://www.dwd.de) measured in the nearest pollen count station in that region.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Ralph Mösges

Collaborators

University Hospital of Cologne

Investigators

  • Study Director: Matthias Kramer, Prof. Dr., Bencard Allergie GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimated)

October 20, 2015

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC Grass Booster 01 2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergic Rhinitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe