Ability of a Cat Food to Reduce Respiratory Symptoms in Cat Allergic Patients (CATS)

Evaluation of the Ability of a Cat Food to Reduce Respiratory Symptoms in Cat Allergic Patients: Pilot Study

Cat allergy is the most common animal allergy, affecting approximately 1 in 5 adults worldwide. The prevalence of allergy to furry animals is increasing, and cat allergy is a major risk factor for the development of asthma and rhinitis.

Fel-d1 is the major feline allergen, to which 95% of cat allergic people react. All cats produce Fel-d1 regardless of breed, age, coat type, sex or weight. Fel-d1 is contained primarily in the saliva and sebum of cats.

This allergy manifests itself as allergic rhinitis (AR) (sneezing, cold, coughing, conjunctivitis with watering and itching), severe asthma, and irritation and swelling of the skin when scratched.

A new approach to managing cat allergies is to neutralize the allergens at the source by feeding domestic cats a diet containing anti-Fel-d1 IgY antibodies. The purpose of this pilot study is to determine whether feeding domestic cats a food containing an egg product with anti-Fel d1 IgY (PRO PLAN® LIVECLEAT®) induces a reduction of allergic symptoms in their owners.

Study Overview

• Status: Recruiting
• Conditions: Rhinitis, Allergic
• Intervention / Treatment: Other: Cats fed with PRO PLAN® LIVECLEAT®

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Batot Géraldine, PhD; Phone Number: +33 6 08 82 81 47; Email: geraldine.batot@kyomed.com

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Cabinet médical Lion de Raspail
    • Contact: Pham-Thi Nan, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

a total of 50 Allergic patient to cats is expected.

Description

Inclusion Criteria:

• Uncontrolled allergic rhinitis (with or without treatment)
• Persistent allergic rhinitis with worsening of symptoms upon exposure to cats
• Presence of one or two cats in the household, whose diet consists mainly of dry kibble
• Agreement of the patient to change the food of the cat(s) and to feed it exclusively with the test kibbles during the study.
• Diagnosis of cat allergy defined by a positive prick test to standardized cat allergen or cat-specific IgE.
• Absence of allergy to pollens emitted in the region during the 4 months following the inclusion date, confirmed by a negative skin test.
• Person owning an android and/or IOS smartphone and having the possibility to connect to the internet (via phone subscription or WIFI connection),
• Person who agrees to install the MASK-air application (medical device) on his personal smartphone,
• Person having read and understood the information note and having signed their participation agreement before any specific procedure of the study.

Exclusion Criteria:

• Person planning to be away from the cat(s) for more than one week/month in the 4 months following the inclusion visit
• Patient who has had a new cat in the home for less than one month
• Patient in regular contact with other animals to which they are allergic
• Patient with uncontrolled asthma
• Patient receiving immunotherapy for cat allergies
• Patient participating or having participated in an allergic rhinitis study within the last 30 days or 5 half-lives of study medication
• Person who has difficulty understanding or reading the information
• Person declaring to be under guardianship, curatorship or safeguard of justice.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the global Visual Analogic Scale (VAS) mean from Baseline period (Day 0- Day 15) at end period (Day 98-Day112)	The approach will be considered beneficial if there is a statistically significant decrease in this criterion on the D98-J112 period compared to the baseline.	Baseline (Day 0- Day 15) and observation period (Day 98-Day112)

Collaborators and Investigators

• Sponsor: MASK-air SAS
• Investigators: Principal Investigator: Nan Pham-Thi, Dr, Allergologist

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Anticipated): April 5, 2023
• Study Completion (Anticipated): April 15, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Signs and Symptoms, Respiratory
• Other Study ID Numbers: KM00232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No