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Completed

NCT Number: NCT04207697

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander

Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Cat Dander in allergic patients

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Key information

Conditions

Rhinoconjunctivitis With or Without Allergic Asthma

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Campus de la Salud University Hospital, Granada, Andalusia, Spain

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About this study

This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized with cat dander allergic patients (children and adults) in routine medical care. Patients receive a rush schedule administration every month for a year. They attend at least 5 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of the age of 12 years and older suffering from a clinically relevant cat dander induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
  • Positive skin testing
  • Positive Serum-Specific IgE determination
  • Informed consent

Exclusion criteria

  • Patients suffering from acute or chronic infections or inflammations
  • Patients suffering from uncontrolled asthma
  • Patients with a known autoimmune disease
  • Patients with active malignant disease
  • Patients requiring beta-blockers
  • Patients having any contraindication for the use of adrenaline
  • Patients with previous immunotherapy with this allergen or another allergen with cross-reaction
  • Patients with immunotherapy treatment at the time of inclusion

Treatment and study plan

Beltavac® Polymerized with cat dander

Biological

Adminstration of Beltavac® Polymerized with cat dander according to the routine clinical practice

Primary outcomes

  1. Numbers of treatment-related local and systemic reactions

    Time frame: 12 months

    Number of adverse reactions occurred during the treatment period and classified according to the WAO standards

Secondary outcomes

  1. Combined Symptom and Medication Score of Rhinoconjunctivitis

    Time frame: 12 months

    The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)

  2. Combined Symptom and Medication Score of Asthma

    Time frame: 12 months

    The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)

  3. Visual analogue Scale Score

    Time frame: 12 months

    Psycometric scale that assesses the global allergic disease discomfort. It is a 10 cm line representing severity from 0:"no symptoms" to 10 "highest level of symptoms"

  4. IgE and IgG4 specific quantification

    Time frame: 6 and 12 months

    IgE and IgG4 quantification in serum at baseline, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Probelte Pharma S.L.U.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 23, 2019
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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