Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Drug: ORALVAC COMPACT BÄUME
- Registration Number
- NCT03097432
- Lead Sponsor
- University Hospital of Cologne
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 164
- Patients of the age of 2 years and older suffering from a tree pollen induced seasonal allergic rhinitis
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ORALVAC COMPACT BÄUME 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
UHCologne
🇩🇪Cologne, Germany