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

Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04389034
• Other study ID #: PQ EAST V1.0
• Status: Completed
• Start date: April 22, 2020
• Est. completion date: October 5, 2020

Study information

• Verified date: February 2021
• Source: Allergy Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: October 5, 2020
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Pollinex Quattro with tree- and grass pollen extracts and their mixtures
retrospective analysis of patient records of allergen-specific immunotherapy

Locations

Country	Name	City	State
Germany	Outpatient Center Dr Stollewerk/Niebecker	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Allergy Therapeutics

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in allergen specific IgE after allergen-specific immunotherapy	Efficacy	baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Secondary	Change in medication usage after allergen-specific immunotherapy	Efficacy	baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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