SubCutaneous Immunotherapy Treatment Effect (CITE) study

Phase 4

Completed

• Conditions: hayfever; 10001708; allergic rhinitis

• Registration Number: NL-OMON36931
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

18 years or older
Clinically relevant moderate to severe allergic rhinitis due to a sensitization for one or two allergens: birch pollen (BP), and/or house dust mite (HM).
Positive nasal challenge test to the relevant allergen (BP and/or HM)

Exclusion Criteria

Severe/instable asthma
Previous immunotherapy
General contraindications to immunotherapy (according to international guidelines; i.e. history of anaphylaxis; immunosuppressive treatment etc).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For inhalant allergy (BP or HM): SIT-responsiveness will be defined by nasal<br /><br>responsiveness to BP or HM before and after 2 years of treatment. Participants<br /><br>will be divided in SIT-responders and non-responders according to the outcome<br /><br>of nasal challenge tests.<br /><br>For birch pollen-associated food allergy: Responsiveness to BP-SIT as defined<br /><br>by oral challenge tests to Mal d 1 - the major allergen in apple * before and<br /><br>after 2 years of treatment. Participants will be divided in BP-SIT responders<br /><br>and non-responders according to the outcome of oral challenge tests. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>For BP or HM allergy:<br /><br>Additional study parameters to evaluate the effects of immunotherapy are<br /><br>changes in i) nasal responsiveness after 1 year, ii) immediate skin reactivity<br /><br>after one and two years, respectively, and iii) assessment of global scores on<br /><br>the symptoms of allergic rhinitis after one and two years<br /><br>For BP allergy and apple sensitization:<br /><br>Additional study parameters are changes in i) responsiveness to open apple<br /><br>challenges, after one and two years of BP-SIT ii) responsiveness to oral<br /><br>challenge with Mal d 1 after 12 months iii)immediate skin reactivity to birch<br /><br>pollen-associated food allergens (i.e. apple, peach and hazelnut) after one and<br /><br>two years of BP-SIT.</p><br>