Rhinitis, AllergicCATSNCT05656482
Ability of a Cat Food to Reduce Respiratory Symptoms in Cat Allergic Patients
An observational study of Rhinitis, Allergic, run by MASK-air SAS at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rhinitis, Allergic
- What is being tested?
- Cats fed with PRO PLAN® LIVECLEAT®
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2022to 15 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: a total of 50 Allergic patient to cats is expected.
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cabinet médical Lion de Raspail
Paris, 75014
Pham-Thi Nan, Dr
About this study
Official title: 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.
Read more
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
- Being tested
- Cats fed with PRO PLAN® LIVECLEAT®
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cats fed with PRO PLAN® LIVECLEAT®Other
Patient with domestic cats fed with an egg product containing anti-Fel d1 IgY (PRO PLAN® LIVECLEAT®)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0- Day 15) and observation period (Day 98-Day112)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start6 May 2022
- Primary completion5 Apr 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MASK-air SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nan Pham-Thi, Dr, Principal investigator, Allergologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656482
- Sponsor's protocol ID
- KM00232
- Acronym
- CATS
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38676659
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Ability of a Cat Food to Reduce Respiratory Symptoms in Cat Allergic Patients: Pilot Study
- ClinicalTrials.gov ID
- NCT05656482
- Acronym / sponsor ID
- CATS / KM00232
- Conditions
- Rhinitis, Allergic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MASK-air SASIndustry (pharma, biotech, devices)
- Study start
- 6 May 2022 (actual)
- Primary completion
- 5 Apr 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- a total of 50 Allergic patient to cats is expected.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cats fed with PRO PLAN® LIVECLEAT®Patient with domestic cats fed with an egg product containing anti-Fel d1 IgY (PRO PLAN® LIVECLEAT®) | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Derived from this study: PubMed 38676659Bousquet 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.
- Individual participant dataSharing planned: No
Related trials for Rhinitis, Allergic
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nan Pham-Thi, Dr principal investigator
Allergologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic, run by MASK-air SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Batot Géraldine, PhD (+33 6 08 82 81 47, geraldine.batot@kyomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05656482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.