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NCT Number: NCT03097432

Non-interventional Study to Assess the Tolerability, the Safety Profile and the Adherence of Different Up-dosing Schemes for a Sublingual Immunotherapy Treatment

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UHCologne

Cologne, 50931, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORALVAC COMPACT BÄUME

Drug

Primary outcomes

  1. Incidence of treatment-emergent adverse events (Safety and Tolerability)

    Time frame: 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.

  2. Improvement of rhinoconjunctivitis symptoms and intake of rescue medication (efficacy)

    Time frame: 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 outcomes

  1. Evaluation of tolerability and safety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital of Cologne

Other

Collaborators

  • Bencard Allergie GmbH

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2017
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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