Cat Hair Extract for Allergic Rhinitis

(AP-CAT Trial)

Overseen By Sarah Garvey, RPN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Queen's University

Must not be taking: Short-acting beta agonists, Corticosteroids, Biologics

Disqualifiers: Pregnancy, Asthma, Respiratory infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a cat allergen extract (Allergenic Extract Standardized Cat Hair AP) can trigger symptoms of allergic rhinitis, such as a runny nose and sneezing, in individuals allergic to cats. It also examines whether this treatment alters certain allergy-related substances in the blood and nose. The trial includes both cat-allergic and non-allergic individuals to compare their reactions. Ideal candidates for this study are those who have experienced sneezing and a runny nose around cats for more than two years. As an unphased trial, this study allows participants to contribute to foundational research that could enhance the understanding and management of cat allergies.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that participants must comply with washout periods for restricted medications. It's best to discuss your specific medications with the study team.

What prior data suggests that this allergen extract is safe for use in humans?

Research has shown that the Allergenic Extract Standardized Cat Hair, known as AP Cat, is generally safe when administered by trained medical professionals. Studies have found a low risk of side effects. However, severe allergic reactions, though rare, can occur and may include life-threatening symptoms. Therefore, healthcare providers should administer AP Cat, as they are prepared to handle such situations.

In summary, while AP Cat is usually well-tolerated, there remains a small chance of serious allergic reactions. Trial participants are closely monitored to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for allergic rhinitis, such as antihistamines and nasal corticosteroids, the allergenic extract standardized cat hair AP offers a targeted approach by using a cat hair extract. This method aims to desensitize the immune system specifically to cat allergens, potentially reducing symptoms more effectively in individuals with cat allergies. Researchers are excited about this treatment because it could provide a more personalized and long-lasting solution for those who struggle with cat-induced allergic rhinitis, addressing the root cause rather than just managing symptoms.

What evidence suggests that this treatment might be an effective treatment for allergic rhinitis?

Research has shown that using cat hair and dander extracts in immunotherapy can greatly reduce allergic reactions. For instance, a study with 22 patients found that this treatment lessened skin and breathing issues caused by cat allergens. In this trial, participants will be exposed to the Allergenic Extract Standardized Cat Hair AP to assess its effectiveness. Allergen immunotherapy (AIT) effectively controls symptoms and prevents worsening for airborne allergens like cat hair. Overall, evidence suggests that using cat hair extract could effectively manage allergies in people sensitive to cats. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people with cat allergies to see if a cat allergen extract (AP Cat) causes allergic rhinitis symptoms. Participants will be exposed to AP Cat intranasally and have samples collected. They must visit the study site three times, complete symptom questionnaires, and may not have conditions that could interfere with the trial.

Inclusion Criteria

Able to understand and willing to provide written informed consent

Able and willing to comply with study requirements

Allergic participants must have a minimum 2-year history of AR symptoms upon exposure to cats

Exclusion Criteria

Pregnant, lactating, or actively trying to become pregnant

I am currently on or recently finished cat allergy shots.

History of any disease or disorder that, in the judgement of the investigator, would impact participant's safety or study results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

1 visit (in-person)

Nasal Allergen Challenge (NAC) Exposure

Participants are exposed to the AP Cat allergen via nasal administration to induce allergic rhinitis symptoms

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after NAC exposure, with nasal fluid and blood samples collected

24 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Allergenic Extract Standardized Cat Hair AP

Trial Overview The study tests whether AP Cat induces nasal allergy symptoms in cat-allergic individuals when given through the nose. It also checks if it affects allergy-related elements in blood and nasal fluid. The comparison is between allergic and non-allergic participants' reactions over time after exposure.

How Is the Trial Designed?

Group I: Non-Allergic Participant AP-Cat Challenge Experimental Treatment 1 Intervention

Group II: Allergic Participant AP-Cat Challenge Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Queen's University

Lead Sponsor

Kingston Health Sciences Centre

Lead Sponsor

Trials

312

Recruited

112,000+

Published Research Related to This Trial

In a study of 10 patients with cat asthma and hay fever, exposure to ambient cat allergens in a room with living cats caused a significant drop in lung function (20% decrease in FEV1), demonstrating the real-world impact of cat allergens on sensitive individuals.

The doses of cat allergen measured in the room air correlated well with those required to induce similar respiratory effects in controlled bronchial challenge tests, indicating that ambient exposure can be as potent as direct allergen exposure in triggering asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose of cat (Felis domesticus) allergen 1 (Fel d 1) that induces asthma. Van Metre, TE., Marsh, DG., Adkinson, NF., et al.[2019]

In a study of 22 patients with cat asthma, immunotherapy using cat-hair and dander extract significantly reduced skin and bronchial responses to cat allergens after one year of treatment, indicating its efficacy in managing cat allergies.

The immunotherapy was well tolerated with only mild and infrequent systemic reactions, and it led to increased levels of IgE and IgG antibodies specific to cat allergens, suggesting an immune response that could help in long-term allergy management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy for cat asthma. Van Metre, TE., Marsh, DG., Adkinson, NF., et al.[2019]

The U.S. FDA standardized 19 allergen extracts between 1987 and 1998, ensuring consistent potency and safety across different manufacturers and lots, which enhances their reliability for allergy treatment.

Standardized extracts provide improved efficacy by guaranteeing the presence of significant allergens, making them safer and more effective compared to nonstandardized extracts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized allergen extracts for allergen immunotherapy. Nelson, HS.[2022]

In a double-blind trial involving 10 asymptomatic patients with cat-induced asthma, those receiving active immunotherapy showed a significant reduction in skin reactivity and bronchial sensitivity to cat allergens after 3 to 4 months of treatment.

No significant changes were observed in bronchial response to histamine for either the active treatment or placebo group, indicating that while immunotherapy was effective for cat allergens, it did not affect overall bronchial reactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy in cat-induced asthma. Double-blind trial with evaluation of bronchial responses to cat allergen and histamine. Taylor, WW., Ohman, JL., Lowell, FC.[2019]

Sublingual immunotherapy (SLIT) using house dust mite and grass pollen extracts has shown positive effects in treating allergic rhinitis, based on a review of nine randomized controlled trials (RCTs) with no observed bias.

Despite the benefits of SLIT compared to placebo, the results should be interpreted cautiously due to significant variability in treatment protocols and dosing across the studies, highlighting the need for more standardization in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

House Dust Mite and Grass Pollen Allergen Extracts for Seasonal Allergic Rhinitis Treatment: A Systematic Review. Sialakis, C., Antoniou Sialaki, P., Frantzana, A., et al.[2022]

A study analyzing 27,788 prescriptions for cat allergen immunotherapy (AIT) found that adherence to recommended dosing guidelines significantly improved after updates to practice parameters, with prescriptions in the recommended range increasing from 18.0% to 82.6%.

The findings suggest that clearer dosing recommendations in practice parameters positively influence prescribing patterns among allergists, leading to more consistent and effective treatment for cat allergy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of allergen immunotherapy practice parameters on cat extract prescribing patterns, 1993-2009. Robertson, BD., McCoy, RL., Nelson, MR., et al.[2015]

High-performance liquid chromatography (HPLC) analysis of cat and dog saliva and hair extracts identified allergenic molecules, particularly noting that components with molecular weights between 35,000 and 200,000 showed inhibitory activity in allergy tests.

Albumin was specifically identified as one of the active components responsible for allergic reactions, and the study found no significant differences in allergenic fractions between different sources of cat and dog samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Studies on allergens of mammalian origin. Calam, DH., Davidson, J., Ford, AW.[2019]

Natural exposure cat rooms have been crucial for understanding cat allergen-induced allergic rhinitis (AR), but their variability in allergen levels and study designs highlight the need for standardized protocols.

Allergen exposure chambers (AECs) effectively mimic real-world exposure and allow for large sample studies, while nasal allergen challenges (NACs) are more cost-effective and standardized for smaller cohorts, suggesting that using both methods together could provide a comprehensive understanding of cat allergen-induced AR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of Cat Allergy Using Controlled Methodology-A Review of the Literature and a Call to Action. Hossenbaccus, L., Linton, S., Ramchandani, R., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06828484

Allergenic Extract Standardized Cat Hair AP in an Allergic ... The goal of this study is to learn if a cat allergen extract known as Allergenic Extract Standardized Cat Hair Acetone Precipitated (AP Cat) can induce ...

2. withpower.com withpower.com/trial/phase-allergic-rhinitis-disorder-1-2025-5d860

Cat Hair Extract for Allergic Rhinitis (AP-CAT Trial) In a study of 22 patients with cat asthma, immunotherapy using cat-hair and dander extract significantly reduced skin and bronchial responses to cat allergens ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06828484/allergenic-extract-standardized-cat-hair-ap-in-an-allergic-rhinitis-model

Allergenic Extract Standardized Cat Hair AP in an Allergic ... The goal of this study is to learn if a cat allergen extract known as Allergenic Extract Standardized Cat Hair Acetone Precipitated (AP Cat) ...

4. stagrallergy.com stagrallergy.com/wp-content/uploads/greer-allergenic-extracts-standardized-cat-hair-felis-catus-package-insert.pdf

greer-allergenic-extracts-standardized-cat-hair-felis-catus ... The efficacy of immunotherapy for Type I hypersensitivity (i.e. allergy) to airborne allergens3 including cat hair/dander has been well established.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5893203/

Immunotherapy for pet allergies - PMC Accordingly, AIT with animal allergen extract was favorable against symptomatic deterioration (SMD 0.47 (CI 0.24 to 0.92)), analyzed by four studies. Analyses ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06828484?term=FELIS%20CATUS%20HAIR&rank=6

Allergenic Extract Standardized Cat Hair AP in an Allergic ... The main questions this study aims to answer are: Does AP Cat induce nasal symptoms of allergic rhinitis in cat-allergic participants when delivered ...

7. hsallergy.com hsallergy.com/wp-content/uploads/345038-H08-Cat-Hair_8_5x11.pdf

ALLERGENIC EXTRACT STANDARDIZED CAT HAIR ... WARNINGS. This product is intended for use only by licensed medical personnel experienced in administering allergenic extracts and trained to provide ...

8. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6f9e5a38-738c-470f-b9cf-4fcef6bc7f01

ALLERGENIC EXTRACT STANDARDIZED CAT HAIR AP ... adverse reaction frequency data for allergenic extract administration for testing and treatment show that risk is low. ... A “double-blind” study of treatment ...

9. jacionline.org jacionline.org/article/0091-6749(94)90233-X/pdf

Safety and efficacy of oral immunotherapy with ... The double-blind studies demonstrating efficacy with oral immunotherapy for the most part used large allergen doses up to. 200 times the cumulative doses ...