CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Nasal Provocation with Birch Extract +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03644680
NCT03644680N/ACompleted

Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study

Medical University of Vienna·interventional·Posted Aug 23, 2018·Updated Oct 10, 2019

In Brief

A clinical study evaluating Nasal Provocation with Birch Extract and Nasal Provocation with NaCl 0.9% for Allergic Rhinitis and Allergic Inflammation. Completed, enrolled 36 participants across 1 site.

Detailed Summary

IgE-associated allergy is a hypersensitivity disease affecting more than 25% of the population in industrialised countries. The recognition of allergen by immunoglobulin E (IgE) plays a central role in the cause of allergic diseases. Both seasonal and nasal provocation studies have demonstrated the rise in specific IgE after allergen exposure. Additionally changes in other clinical and immunological parameters (e.g. nasal blockage, mast cell and basophil sensitivity, various cytokines or T cell profiles) in response to allergen exposure have been described. However the time sensitive interplay of these various factors such as the relationship between rise in IgE levels and change in basophils sensitivity or cytokine profiles is not yet fully understood. Clarifying how these various factors interact and contribute to immunological responses to allergen, is crucial for the development of new therapeutic approaches. The investigators aim to address these questions through a study following 36 Birch allergic patients after provocation with allergen or placebo over a peroid of 6 weeks to 1 year.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 23, 2018
Enrollment StartSep 24, 2018
Primary CompletionOct 4, 2019
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.9 years ago

Interventions

Nasal Provocation with Birch Extractother

Nasal spray containing birch extract from Allergopharma

Nasal Provocation with NaCl 0.9%other

Nasal spray containing sterile sodium chloride 0.9%