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

NCT05656482 | Unknown

• 1 other identifier: KM00232
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (1)

• 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)

Interventions

Cats fed with PRO PLAN® LIVECLEAT® OTHER

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

a total of 50 Allergic patient to cats is expected.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MASK-air SAS: lead

Study Sites (1)

Cabinet médical Lion de Raspail

Paris, 75014, France

RECRUITING

Related Publications (1)

• Bousquet J, Gherasim A, de Blay F, Mathieu-Dupas E, Batot G, Laune D, Sousa-Pinto B, Zuberbier T, Pham-Thi N; MASK-cat study group. Proof-of-concept study of anti-Fel d 1 IgY antibodies in cat food using the MASK-air(R) app. Clin Transl Allergy. 2024 May;14(5):e12353. doi: 10.1002/clt2.12353.

  PMID: 38676659 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nan Pham-Thi, Dr

  Allergologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Batot Géraldine, PhD

CONTACT

+33 6 08 82 81 47; geraldine.batot@kyomed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 19, 2022
• Study Start: May 6, 2022
• Primary Completion: April 5, 2023
• Study Completion: April 15, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)