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

Rhinitis, Allergic Clinical Trial

— CATS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656482
• Other study ID #: KM00232
• Status: Recruiting
• Start date: May 6, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: March 2023
• Source: MASK-air SAS
• Contact: Batot Géraldine, PhD
• Phone: +33 6 08 82 81 47
• Email: geraldine.batot[@]kyomed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 15, 2023
• Est. primary completion date: April 5, 2023
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Signs and Symptoms, Respiratory

Intervention

Other:
• Cats fed with PRO PLAN® LIVECLEAT®
Patient with domestic cats fed with an egg product containing anti-Fel d1 IgY (PRO PLAN® LIVECLEAT®)

Locations

Country	Name	City	State
France	Cabinet médical Lion de Raspail	Paris

Sponsors (1)

Lead Sponsor	Collaborator
MASK-air SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)