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Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment

NCT03097432 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 164

Last updated 2017-10-25

No results posted yet for this study

Summary

This prospective open multi-centre non-interventional study initiated to document the up-dosing period of children and adults with allergic rhinoconjunctivitis and/or allergic asthma treated with a SLIT containing purified, aqueous extracts of birch, alder, and hazel pollen. The following up-dosing schemes are freely selectable: scheme A consists of an up-dosing period of 12 days at the patient´s home using the standardized pollen extract in three different solution strengths to reach the maximum dose; scheme B is performed only with the highest solution strength at the physician's office within 2 hours; and the new scheme C which is a regimen for initiation at the physician's office and continuation at the patient's home also exclusively using the highest solution strength and takes 4 days. Data are documented by physicians and in patients´ diaries.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

ORALVAC COMPACT BÄUME

Sponsors & Collaborators

  • Bencard Allergie GmbH

    collaborator OTHER

  • University Hospital of Cologne

    lead OTHER

Principal Investigators

  • Matthias Kramer, Prof. Dr. · Bencard Allergie GmbH

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-20
Primary Completion
2017-10-19
Completion
2017-10-19

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03097432 on ClinicalTrials.gov