Not recruiting
Investigational
Study on the Effectiveness of Cup a 1 Immunotherapy for Patients with Moderate to Severe Allergic Rhinoconjunctivitis with or without Controlled Asthma
Investigational
- Participants:All ages
Cupressus arizonica, protein CUP A 1
- 0 / 1
- trials open to patients / all trials
- 1+
- Countries
About the substance
Table of contents
- What is Cupressus arizonica, protein CUP A 1?
- How does Cupressus arizonica, protein CUP A 1 work?
- Which conditions is it used or studied for?
- How is Cupressus arizonica, protein CUP A 1 given?
- What do the clinical trials show?
- What side effects are known?
What is Cupressus arizonica, protein CUP A 1?
Cupressus arizonica, protein CUP A 1 is a purified and isolated major allergen protein derived from the pollen of the Arizona cypress tree (Cupressus arizonica). In the product records of the European Union Clinical Trials Information System it appears under the registry name CUPRESSUS ARIZONICA, PROTEIN CUP A 1, with the product name Cup a 1.[1] It is classified in the therapeutic area of immune system diseases.[1] The substance is an investigational allergen immunotherapy with no marketing authorisation in the product records.[1] It is supplied by Diater Laboratorio de Diagnóstico y Aplicaciones Terapéuticas S.A. and is part of a fixed combination in two product records.[1] A related allergenic extract, Cupressus arizonica pollen, is also listed among non-standardised allergenic labels for injection in a US product label.[2]
How does Cupressus arizonica, protein CUP A 1 work?
The clinical trial record describes the treatment as specific immunotherapy with the purified and isolated protein Cup a 1, administered subcutaneously in patients sensitised to this allergen.[1] Allergen immunotherapy works by exposing the immune system to controlled amounts of a specific allergen, in this case the major cypress pollen protein Cup a 1, with the aim of modifying the allergic response over time. The trial record itself does not provide further molecular detail on the mechanism.
Which conditions is it used or studied for?
- Allergic rhinoconjunctivitis — inflammation of the nose and eyes caused by an allergic reaction, studied in people sensitised to Cupressaceae pollen, with or without asthma.[1]
How is Cupressus arizonica, protein CUP A 1 given?
According to the product records, the pharmaceutical form is a suspension for injection and the route of administration is subcutaneous use.[1] In the completed Phase 3 trial, Cup a 1 was administered subcutaneously at two dose levels: 2.4 micrograms and 5.6 micrograms.[1] The placebo was designed to match the active treatment in appearance, packaging, interval, route and method of administration, and consisted of 0.9% saline solution with mannitol plus histamine.[1]
What do the clinical trials show?
One completed Phase 3 trial is recorded in the EU Clinical Trials Information System.[1] It was a randomised, double-blind, placebo-controlled study conducted at various hospitals, in which neither patients nor investigators knew which treatment each participant received.[1] The trial enrolled 150 participants with allergic rhinoconjunctivitis, with or without asthma, who were sensitised to Cupressaceae pollen.[1] The primary outcome measured efficacy using a symptom frequency and severity score together with the Combined Symptom and Medication Score (CSMS), obtained through a questionnaire completed by the patient during two successive pollen seasons.[1] The study compared two subcutaneous doses of Cup a 1 against placebo.[1]
What side effects are known?
No side effect information specific to Cupressus arizonica, protein CUP A 1 is provided in the available sources.
Conditions where Cupressus arizonica, protein CUP A 1 is being studied
Each condition opens its own overview and trial list
Trials with Cupressus arizonica, protein CUP A 1
Recruiting trials first
Quick filters