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

Trial Summary

What is the purpose of this trial?

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 allergic rhinitis (AR) in a nasal allergen challenge model in cat-allergic people. The main questions this study aims to answer are: 1. Does AP Cat induce nasal symptoms of allergic rhinitis in cat-allergic participants when delivered intranasally? 2. Does AP Cat reduce elements in the blood and nose that are known to be associated with allergies? Both allergic and non-allergic participants will be recruited into this study. Allergic participants will: * Be challenged with AP Cat via the Nasal Allergen Challenge (NAC), which involves administration of this allergen extract directly into the nose. * Have nasal fluid and blood samples collected at various timepoints up to 24 hours after exposure to the allergen in the NAC. * Visit the study site three separate times: 1. At screening (Visit 1), to determine eligibility to participate in this study 2. At the baseline NAC visit (Visit 2) 3. At the 24-hour post-NAC follow-up visit (Visit 3) * Complete nasal symptom questionnaires. * Complete a questionnaire about their regular exposure to cats. Non-allergic participants will: * Be challenged with AP Cat via the NAC, which involves administration of this allergen extract directly into the nose. * Have nasal fluid and blood samples collected at various timepoints up to 24 hours after exposure to the allergen in the NAC. * Visit the study site three separate times: 1. At screening (Visit 1), to determine eligibility to participate in this study 2. At the baseline NAC visit (Visit 2) 3. At the 24-hour post-NAC follow-up visit (Visit 3) * Complete nasal symptom questionnaires. This study will compare the nasal symptoms and allergic markers collected from the nasal fluid and blood samples between allergic and non-allergic participants at baseline and various timepoints post-NAC exposure.

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 data supports the effectiveness of the treatment Allergenic Extract Standardized Cat Hair AP for allergic rhinitis?

Research shows that cat extract allergen immunotherapy is effective for cat allergies, with recommended dose ranges established. Additionally, studies on cat-induced asthma demonstrate that cat extract immunotherapy reduces skin and bronchial reactions, suggesting potential benefits for allergic rhinitis as well. ^{1 2 3 4 5}

Is cat hair extract safe for use in humans?

Research shows that cat hair extract used in immunotherapy is generally well tolerated, with mild and infrequent systemic reactions reported in patients with cat asthma. ^{1 2 3 5 6}

How does the cat hair extract treatment for allergic rhinitis differ from other treatments?

Cat hair extract treatment for allergic rhinitis is unique because it involves allergen immunotherapy, which gradually exposes the patient to small amounts of cat allergens to build up tolerance. This approach is different from typical allergy medications that only manage symptoms without addressing the underlying sensitivity to cat allergens. ^{1 2 3 7 8}

Eligibility Criteria

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

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

Able to understand and willing to provide written informed consent

Able and willing to comply with study requirements

Exclusion Criteria

My doctor found significant health issues during my physical exam.

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

Pregnant, lactating, or actively trying to become pregnant

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of allergen immunotherapy practice parameters on cat extract prescribing patterns, 1993-2009. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Dose of cat (Felis domesticus) allergen 1 (Fel d 1) that induces asthma. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy for cat asthma. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

House Dust Mite and Grass Pollen Allergen Extracts for Seasonal Allergic Rhinitis Treatment: A Systematic Review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Immunotherapy in cat-induced asthma. Double-blind trial with evaluation of bronchial responses to cat allergen and histamine. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Study of Cat Allergy Using Controlled Methodology-A Review of the Literature and a Call to Action. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Studies on allergens of mammalian origin. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Standardized allergen extracts for allergen immunotherapy. [2022]