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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03097432

Enrollment

164

Registered

2017-03-31

Start date

2016-10-20

Completion date

2017-10-19

Last updated

2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Brief 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.

Interventions

DRUGORALVAC COMPACT BÄUME

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment-emergent adverse events (Safety and Tolerability)	up to 12 days of the up-dosing phase	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.
Improvement of rhinoconjunctivitis symptoms and intake of rescue medication (efficacy)	through study completion, tree pollen season 2017	Efficacy will be assessed by the improvement of rhinoconjunctivitis symptoms and intake of rescue medication during the tree pollen season 2017

Secondary

Measure	Time frame	Description
Evaluation of tolerability and safety	up to 12 days of the up-dosing phase	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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026