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

Completed

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

• Registration Number: NCT04389034
• Lead Sponsor: Allergy Therapeutics

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.

Study Timeline

• Study Start: 2020-04-22
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-15
• Primary Completion: 2020-10-05
• Study Completion: 2020-10-05
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults	Pollinex Quattro with tree- and grass pollen extracts and their mixtures	Patients with IgE-induced Rhinitis, Conjunctivitis and/or asthma due to tree- and/or grass pollen induced allergy

Primary Outcome Measures

Name	Time	Method
Change in allergen specific IgE after allergen-specific immunotherapy	baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)	Efficacy

Secondary Outcome Measures

Name	Time	Method
Change in medication usage after allergen-specific immunotherapy	baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)	Efficacy
Change in FEV1 (forced expiratory volume at one second; measured in %) after allergen-specific immunotherapy	baseline, 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 immunotherapy	baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)	Efficacy
Assessment of allergic eye symptoms (itching, tearing, redness, feeling of pressure) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy	baseline, post-treatment, 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 immunotherapy	baseline, post-treatment, at least 3 years of allergen-specific immunotherapy	Efficacy
Assessment of allergic lung/bronchial symptoms (shortness of breath, cough), on a scale 0 -10 (none - severe) after allergen-specific immunotherapy	baseline, post-treatment, at least 3 years of allergen-specific immunotherapy	Efficacy

Trial Locations

Locations (1)

Outpatient Center Dr Stollewerk/Niebecker; 🇩🇪 Cologne, Germany