Influence of Specific Immunotherapy With Pollinex Quattro (Tree-/Grass Pollen) on Allergen-specific Immunoglobulin E (IgE) Levels

February 5, 2021 updated by: Allergy Therapeutics

Retrospective Data Collection Based on Patient Records and Questionaire Based Data of Therapy Results of Allergen-specific Immunotherapy With Pollinex Quattro With Tree and/or Gras Pollen Extracts and Their Mixtures

Primary goal of this non-interventional study is to evaluate the change in level of allergen-specific IgE (EAST class) after allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts and their mixtures under medial routine at adults with tree- and/or grass-medicated pollinosis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this non-interventional study, the change in level of allergen-specific IgE before and after 3 or more years of allergen-specific immunotherapy with Pollinex Quattro in a patient population with tree and/or grass pollen induced pollinosis and/or asthma will be analyzed. In addition, the change in medication usage, asthma status for asthmatic patients after 3, 4 or 5 years of allergen specific immunotherapy will be evaluated. Furthermore, patients will be asked for their change in quality of life after therapy end.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany
        • Outpatient Center Dr Stollewerk/Niebecker

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Allergic patients ≥ 18 years with IgE-mediated rhinitis, conjunctivitis and bronchial asthma on grass and/or tree pollen

Description

Inclusion Criteria:

  • Patients ≥ 18 years
  • Diagnosis of IgE-mediated rhinitis, conjunctivitis and bronchial asthma on grass and/or tree pollen
  • completed allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts or their mixtures according to SMPC effective during immunotherapy

Exclusion Criteria:

  • Contraindication according to Summary of Product Characteristics (SMPC) effective during immunotherapy
  • no additional allergen-specific immunotherapy with another product than Pollinex Quattro

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adults
Patients with IgE-induced Rhinitis, Conjunctivitis and/or asthma due to tree- and/or grass pollen induced allergy
Drug: Pollinex Quattro with tree- and grass pollen extracts and their mixtures
retrospective analysis of patient records of allergen-specific immunotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in allergen specific IgE after allergen-specific immunotherapy
Time Frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Efficacy
baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in medication usage after allergen-specific immunotherapy
Time Frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Efficacy
baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Change in FEV1 (forced expiratory volume at one second; measured in %) after allergen-specific immunotherapy
Time Frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Efficacy
baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Change in lung function resistance (measured in Kpa/l/s) after allergen-specific immunotherapy
Time Frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Efficacy
baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Assessment of allergic eye symptoms (itching, tearing, redness, feeling of pressure) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
Time Frame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
Efficacy
baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
Assessment of allergic nasal symptoms (rhinorrhea, nasal obstruction) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
Time Frame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
Efficacy
baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
Assessment of allergic lung/bronchial symptoms (shortness of breath, cough), on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
Time Frame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
Efficacy
baseline, post-treatment, at least 3 years of allergen-specific immunotherapy

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergy Therapeutics

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PQ EAST V1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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