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Completed

NCT Number: NCT04389034

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

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.

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Key information

Conditions

Rhinitis, Allergic Allergic Asthma Allergic Conjunctivitis Allergy Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Outpatient Center Dr Stollewerk/Niebecker

Cologne, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

retrospective analysis of patient records of allergen-specific immunotherapy

Primary outcomes

  1. Change in allergen specific IgE after allergen-specific immunotherapy

    Time frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)

    Efficacy

Secondary outcomes

  1. Change in medication usage after allergen-specific immunotherapy

    Time frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)

    Efficacy

  2. Change in FEV1 (forced expiratory volume at one second; measured in %) after allergen-specific immunotherapy

    Time frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)

    Efficacy

  3. Change in lung function resistance (measured in Kpa/l/s) after allergen-specific immunotherapy

    Time frame: baseline, post-treatment (after at least 3 years of allergen-specific immunotherapy)

    Efficacy

  4. Assessment of allergic eye symptoms (itching, tearing, redness, feeling of pressure) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy

    Time frame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy

    Efficacy

  5. Assessment of allergic nasal symptoms (rhinorrhea, nasal obstruction) , on a scale 0 -10 (none - severe) after allergen-specific immunotherapy

    Time frame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy

    Efficacy

  6. Assessment of allergic lung/bronchial symptoms (shortness of breath, cough), on a scale 0 -10 (none - severe) after allergen-specific immunotherapy

    Time frame: baseline, post-treatment, at least 3 years of allergen-specific immunotherapy

    Efficacy

Sponsors and collaborators

Lead sponsor

Allergy Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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