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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

Sponsored by University Hospital of Cologne

About this trial

Last updated 8 years ago

Study ID

Oralvac Compact Bäume

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
2+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

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

No

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