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
Sponsor study identifier
observational
164
1 country
1
Study Start
October 20, 2016
Actual (reported)Primary Completion
October 19, 2017
Actual (reported)Study Completion
October 19, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 19, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2016
Actual (reported)March 17, 2017
Actual (reported)March 31, 2017
Actual (reported)October 19, 2017
Actual (reported)October 19, 2017
Actual (reported)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
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
Evaluation of tolerability and safety
up to 12 days of the up-dosing phase
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adults, adolescents and children from the age of 2 on, who suffer from seasonal allergic rhinoconjunctivitis causued by tree pollen.
UHCologne
Cologne, 50931, Germany
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.
Matthias Kramer, Prof. Dr.
Bencard Allergie GmbH
164 participants (actual enrollment reported by the registry).
First Submitted
March 17, 2017
First Posted
March 31, 2017
Study Start
October 20, 2016
Actual (reported)Clinical Efficacy and Safety of a Subcutaneous Immunotherapy With gpASIT+™ in Patients With Grass Pollen-induced Allergic Rhinoconjunctivitis
Contact the study team to confirm eligibility.
Primary Completion
October 19, 2017
Actual (reported)Study Completion
October 19, 2017
Actual (reported)Last Updated
October 25, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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