Clinical trial NCT03097432: Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
Collaborators: name: Bencard Allergie GmbH
First posted: 2017-03-31
Enrollment: 164
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults, adolescents and children from the age of 2 on, who suffer from seasonal allergic rhinoconjunctivitis causued by tree pollen.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (Safety and Tolerability)
timeFrame: up to 12 days of the up-dosing phase
measure: Improvement of rhinoconjunctivitis symptoms and intake of rescue medication (efficacy)
timeFrame: through study completion, tree pollen season 2017
Secondary outcomes:
measure: Evaluation of tolerability and safety
timeFrame: up to 12 days of the up-dosing phase
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: UHCologne
Study officials:
affiliation: Bencard Allergie GmbH
name: Matthias Kramer, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Mosges R, Breitruck NY, Allekotte S, Shah-Hosseini K, Dao VA, Zieglmayer P, Birkholz K, Hess M, Bastl M, Bastl K, Berger U, Kramer MF, Guethoff S. Shortened up-dosing with sublingual immunotherapy drops containing tree allergens is well tolerated and elicits dose-dependent clinical effects during the first pollen season. World Allergy Organ J. 2019 Mar 8;12(2):100012. doi: 10.1016/j.waojou.2019.100012. eCollection 2019.