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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05656482
Recruitment Status : Recruiting
First Posted : December 19, 2022
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
MASK-air SAS

Study Description
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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.


Condition or disease Intervention/treatment
Rhinitis, Allergic Other: Cats fed with PRO PLAN® LIVECLEAT®

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Ability of a Cat Food to Reduce Respiratory Symptoms in Cat Allergic Patients: Pilot Study
Actual Study Start Date : May 6, 2022
Estimated Primary Completion Date : April 5, 2023
Estimated Study Completion Date : April 15, 2023
Groups and Cohorts
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Intervention Details:
  • Other: Cats fed with PRO PLAN® LIVECLEAT®
    Patient with domestic cats fed with an egg product containing anti-Fel d1 IgY (PRO PLAN® LIVECLEAT®)

Outcome Measures
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Primary Outcome Measures :
  1. Change of the global Visual Analogic Scale (VAS) mean from Baseline period (Day 0- Day 15) at end period (Day 98-Day112) [ Time Frame: Baseline (Day 0- Day 15) and observation 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
a total of 50 Allergic patient to cats is expected.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05656482


Contacts
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Contact: Batot Géraldine, PhD +33 6 08 82 81 47 geraldine.batot@kyomed.com

Locations
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France
Cabinet médical Lion de Raspail Recruiting
Paris, France, 75014
Contact: Pham-Thi Nan, Dr         
Sponsors and Collaborators
MASK-air SAS
Investigators
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Principal Investigator: Nan Pham-Thi, Dr Allergologist
More Information
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Responsible Party: MASK-air SAS
ClinicalTrials.gov Identifier: NCT05656482    
Other Study ID Numbers: KM00232
First Posted: December 19, 2022    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Signs and Symptoms, Respiratory
Respiratory Tract Infections
Infections
Nose Diseases
 Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases