NCT04389034

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 22, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

April 22, 2020

Last Update Submit

February 5, 2021

Conditions

Rhinitis, AllergicRespiratory Tract InfectionsAllergyAllergic AsthmaAllergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Change in allergen specific IgE after allergen-specific immunotherapy

    Efficacy

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

Secondary Outcomes (6)

  • Change in medication usage after allergen-specific immunotherapy

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

  • 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)

  • 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)

  • 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

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Adults

Patients with IgE-induced Rhinitis, Conjunctivitis and/or asthma due to tree- and/or grass pollen induced allergy

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

Interventions

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

retrospective analysis of patient records of allergen-specific immunotherapy

Adults

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Allergic patients ≥ 18 years with IgE-mediated rhinitis, conjunctivitis and bronchial asthma on grass and/or tree pollen

You may qualify if:

  • 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

You may not qualify if:

  • Contraindication according to Summary of Product Characteristics (SMPC) effective during immunotherapy
  • no additional allergen-specific immunotherapy with another product than Pollinex Quattro

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Center Dr Stollewerk/Niebecker

Cologne, Germany

Location

MeSH Terms

Conditions

Rhinitis, AllergicRespiratory Tract InfectionsHypersensitivityConjunctivitis, Allergic

Interventions

Pollinex Quattro

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System DiseasesInfectionsConjunctivitisConjunctival DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

May 15, 2020

Study Start

April 22, 2020

Primary Completion

October 5, 2020

Study Completion

October 5, 2020

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

DE(1)