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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097432
• Other study ID #: Oralvac Compact Bäume
• Status: Completed
• Phase: N/A
• First received: March 17, 2017
• Last updated: October 24, 2017
• Start date: October 20, 2016
• Est. completion date: October 19, 2017

Study information

• Verified date: October 2017
• Source: University Hospital of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: October 19, 2017
• Est. primary completion date: October 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• ORALVAC COMPACT BÄUME

Locations

Country	Name	City	State
Germany	UHCologne	Cologne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Cologne	Bencard Allergie GmbH, Munich, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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