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

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

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: ORALVAC COMPACT BÄUME

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50931
    • UHCologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults, adolescents and children from the age of 2 on, who suffer from seasonal allergic rhinoconjunctivitis causued by tree pollen.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: ORALVAC COMPACT BÄUME

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events (Safety and Tolerability)	Tolerability and safety will be assessed by the frequency and intensity of local reactions (mouth, lips, pharynx/throat, gastrointestinal tract) and systemic reactions (skin, airways, others) during the up-dosing phase.	up to 12 days of the up-dosing phase
Improvement of rhinoconjunctivitis symptoms and intake of rescue medication (efficacy)	Efficacy will be assessed by the improvement of rhinoconjunctivitis symptoms and intake of rescue medication during the tree pollen season 2017	through study completion, tree pollen season 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of tolerability and safety	Tolerability and safety of the treatment with ORALVAC COMPACT BÄUME will be evaluated by the frequency and intensity of miscellaneous adverse events during the up-dosing phase.	up to 12 days of the up-dosing phase

Collaborators and Investigators

• Sponsor: University Hospital of Cologne
• Collaborators: Bencard Allergie GmbH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2016
• Primary Completion (ACTUAL): October 19, 2017
• Study Completion (ACTUAL): October 19, 2017

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 30, 2017
• First Posted (ACTUAL): March 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: Oralvac Compact Bäume

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO