NCT03014661

Brief Summary

Questionnaire to measure and control the quality of life of patients with hay fever who are treated or were treated with Pollinex quattro

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2015

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

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

January 2, 2017

Last Update Submit

January 5, 2017

Conditions

Rhinitis, Allergic, Seasonal

Keywords

pollinosis, quality of life, specific immunotherapy

Outcome Measures

Primary Outcomes (1)

  • Quality of life questionnaire (DLQI)

    during year one, year two, year three of therapy or within 6 months after completion of therapy

Study Arms (1)

Single group study

Single Group study investigating retrospectively the Quality of life of patients with pollinosis under or after specific immunotherapy with Pollinex quattro

Other: Quality of life under or after therapy with Pollinex quattro

Interventions

Quality of life under or after therapy with Pollinex quattroOTHER

To measure Quality of life using the DLQI-index in year one, year two, year three or six month after therapy with Pollinex quattro plus.

Single group study

Eligibility Criteria

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

Adult persons with hayfever treated with a specific immunotherapy with Pollinex quattro plus (Allergens: birch/alder/Hazel or grass/rye or mugwort)

You may qualify if:

  • Pollinosis/seasonal Rhinitis based on an allergy against birch/alder/Hazel pollen OR grass/rye pollen OR mugwort
  • Therapy with Polinex quattro

You may not qualify if:

  • Age \<18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saarland University Hospital. Department of Dermatology

Homburg, Saarland, 66421, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Pollinex Quattro

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 9, 2017

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 9, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)