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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04389034
Enrollment
113
Registered
2020-05-15
Start date
2020-04-22
Completion date
2020-10-05
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Asthma, Allergic Conjunctivitis, Allergy, Respiratory Tract Infections, Rhinitis, Allergic

Brief summary

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.

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.

Interventions

DRUGPollinex Quattro with tree- and grass pollen extracts and their mixtures

retrospective analysis of patient records of allergen-specific immunotherapy

Sponsors

Allergy Therapeutics
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in allergen specific IgE after allergen-specific immunotherapybaseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)Efficacy

Secondary

MeasureTime frameDescription
Change in FEV1 (forced expiratory volume at one second; measured in %) after allergen-specific immunotherapybaseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)Efficacy
Change in lung function resistance (measured in Kpa/l/s) after allergen-specific immunotherapybaseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)Efficacy
Change in medication usage after allergen-specific immunotherapybaseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)Efficacy
Assessment of allergic nasal symptoms (rhinorrhea, nasal obstruction) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapybaseline, post-treatment, at least 3 years of allergen-specific immunotherapyEfficacy
Assessment of allergic lung/bronchial symptoms (shortness of breath, cough), on a scale 0 -10 (none - severe) after allergen-specific immunotherapybaseline, post-treatment, at least 3 years of allergen-specific immunotherapyEfficacy
Assessment of allergic eye symptoms (itching, tearing, redness, feeling of pressure) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapybaseline, post-treatment, at least 3 years of allergen-specific immunotherapyEfficacy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026