SubCutaneous Immunotherapy Treatment Effect (CITE) study

SubCutaneous Immunotherapy Treatment Effect (CITE) study - CITE study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36931

Enrollment

Registered

2012-07-26

Start date

2012-09-12

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic rhinitis hayfever

Interventions

Routine subcutaneous allergen specific immunotherapy with BP and/or HM extracts

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)