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

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: Completed
• Conditions: Respiratory Tract Infections; Allergy; Rhinitis, Allergic; Allergic Conjunctivitis; Allergic Asthma
• Intervention / Treatment: Drug: Pollinex Quattro with tree- and grass pollen extracts and their mixtures

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: Observational
• Enrollment (Actual): 113

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in allergen specific IgE after allergen-specific immunotherapy	Efficacy	baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in medication usage after 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	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	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	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	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	Efficacy	baseline, post-treatment, at least 3 years of allergen-specific immunotherapy

Collaborators and Investigators

• Sponsor: Allergy Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2020
• Primary Completion (Actual): October 5, 2020
• Study Completion (Actual): October 5, 2020

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Conjunctival Diseases; Rhinitis; Rhinitis, Allergic; Respiratory Tract Infections; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID 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