Clinical trial NCT04389034: Influence of Specific Immunotherapy With Pollinex Quattro (Tree-/Grass Pollen) on Allergen-specific Immunoglobulin E (IgE) Levels
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic
Respiratory Tract Infections
Allergy
Allergic Asthma
Allergic Conjunctivitis
Lead sponsor: Allergy Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-05-15
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in allergen specific IgE after allergen-specific immunotherapy
timeFrame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Secondary outcomes:
measure: Change in medication usage after allergen-specific immunotherapy
timeFrame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
measure: Change in FEV1 (forced expiratory volume at one second; measured in %) after allergen-specific immunotherapy
timeFrame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
measure: Change in lung function resistance (measured in Kpa/l/s) after allergen-specific immunotherapy
timeFrame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
measure: Assessment of allergic eye symptoms (itching, tearing, redness, feeling of pressure) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
timeFrame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
measure: Assessment of allergic nasal symptoms (rhinorrhea, nasal obstruction) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
timeFrame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
measure: Assessment of allergic lung/bronchial symptoms (shortness of breath, cough), on a scale 0 -10 (none - severe) after allergen-specific immunotherapy
timeFrame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Outpatient Center Dr Stollewerk/Niebecker
Study officials:
References: