Allergic Rhinitis Clinical Trial
Official title:
Non-Interventional Study (NIS) on the Tolerability of Sublingual Immunotherapy With LAIS® Mites Tablets in Consideration of the Chosen Titration Schedule in Everyday Practice
Verified date | October 2017 |
Source | University Hospital of Cologne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To expand knowledge on the application and tolerability of immunotherapy with LAIS® Mites allergoid tablets as well as knowledge on the alleviation of symptoms during sublingual therapy in special consideration of the chosen titration schedule in everyday practice.
Status | Completed |
Enrollment | 192 |
Est. completion date | February 28, 2017 |
Est. primary completion date | February 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients aged 18 years or older having allergies within the scope of specifications stated in the patient information leaflet Exclusion Criteria: - Contraindications according to the patient information leaflet |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Cologne |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of the tolerability of SLIT with LAIS® mites allergoid tablets on the description of adverse events and serious adverse events. | The description of adverse events/serious adverse events (AE/SAE) encompasses frequency, intensity, duration, relationship to LAIS® mites tablets and actions taken due to the treatment with LAIS® mites tablets and other concomitant medication. The documentation of adverse events takes place at visit 1, at visit 2 (after titrationphase) and at visit 3 (after first year of treatment). | 13 month |
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