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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

NCT ID: NCT03097432

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-20

Study Completion Date

2017-10-19

Brief Summary

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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.

Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ORALVAC COMPACT BÄUME

This non-interventional study was 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 were 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 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.

ORALVAC COMPACT BÄUME

Intervention Type DRUG

Interventions

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ORALVAC COMPACT BÄUME

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients of the age of 2 years and older suffering from a tree pollen induced seasonal allergic rhinitis

Exclusion Criteria

* Patients suffering from acute or chronic infections or inflammations
* Patients suffering from secondary modifications of the target organ with function impairment (emphysema, bronchiectasis)
* Patients suffering from severe and uncontrolled asthma
* Patients with a known severe autoimmune disease
* Patients with active malignant disease
* Patients requiring beta-blockers
* Patients having any contraindication for the use of adrenaline
* Patients with a hypersensitivity to the excipients of the drug
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bencard Allergie GmbH

OTHER

Sponsor Role collaborator

University Hospital of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Ralph Mösges

Prof. Dr. med. Ralph Mösges

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Kramer, Prof. Dr.

Role: STUDY_DIRECTOR

Bencard Allergie GmbH

Locations

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UHCologne

Cologne, , Germany

Site Status

Countries

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Germany

References

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Mosges R, Breitruck NY, Allekotte S, Shah-Hosseini K, Dao VA, Zieglmayer P, Birkholz K, Hess M, Bastl M, Bastl K, Berger U, Kramer MF, Guethoff S. Shortened up-dosing with sublingual immunotherapy drops containing tree allergens is well tolerated and elicits dose-dependent clinical effects during the first pollen season. World Allergy Organ J. 2019 Mar 8;12(2):100012. doi: 10.1016/j.waojou.2019.100012. eCollection 2019.

Reference Type DERIVED
PMID: 30937138 (View on PubMed)

Other Identifiers

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Oralvac Compact Bäume

Identifier Type: -

Identifier Source: org_study_id