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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03097432
Other study ID # Oralvac Compact Bäume
Secondary ID
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
Health authority
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

Study Design


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 BĂ„UME 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
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