NOVAPAK for Shellfish Allergy

Overseen By Taciano Rocha, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Must not be taking: Beta-blockers, Antihistamines, Prednisone

Disqualifiers: Severe asthma, Heart disease, Stroke, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a nasal packing material called NOVAPAK to determine its safety for individuals with shellfish allergies. Currently, NOVAPAK aids healing and stops bleeding in nasal surgeries. The study aims to ensure it does not trigger allergic reactions in those with shellfish allergies. Participants must have a confirmed shellfish allergy from past reactions or tests. As a Phase 4 trial, NOVAPAK is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

If you are taking antihistamine medications or prednisone, you will need to stop them to participate in the trial. The protocol does not specify other medications, but you should discuss your current medications with the trial team.

What is the safety track record for NOVAPAK Nasal Packing?

Research has shown that NOVAPAK, a nasal packing material derived from a substance found in shellfish, has been used safely in various situations. Notably, similar materials have not caused allergic reactions in people with shellfish allergies during emergencies, such as in military settings. This suggests that NOVAPAK might be safe for individuals with shellfish allergies. However, the manufacturer advises caution because allergic reactions remain possible. This study aims to confirm its safety for these individuals. Overall, existing evidence suggests that NOVAPAK is unlikely to cause allergic reactions, but this study will provide more definitive answers. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike most treatments for shellfish allergies, which often involve strict avoidance and emergency epinephrine for allergic reactions, NOVAPAK offers a new approach through a unique delivery method. This treatment involves applying a specialized nasal packing material that could potentially desensitize the body to shellfish allergens. Researchers are excited because NOVAPAK is designed to be a localized treatment, reducing the risk of systemic side effects and potentially offering a more convenient and non-invasive option for managing shellfish allergies. The novel application technique and targeted approach of NOVAPAK could represent a significant step forward in allergy treatment.

What evidence suggests that NOVAPAK Nasal Packing is safe for patients with shellfish allergy?

Research shows that NOVAPAK, a material used in nasal surgeries, is generally safe and effective. It aids healing, reduces bleeding, and fights bacteria. Although made from chitosan, a substance found in shellfish, it lacks the proteins that typically cause allergic reactions. In emergencies, chitosan bandages have been safely used on people with shellfish allergies without causing reactions. This suggests that NOVAPAK is unlikely to trigger allergies in those with shellfish allergies. The trial will specifically test NOVAPAK's safety for individuals with shellfish allergies to further confirm its safety for these individuals. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with a confirmed shellfish allergy. Candidates must have had a previous allergic reaction to shellfish or convincing clinical history and testing. People taking beta-blockers, those with severe lung, heart, or cerebrovascular diseases, pregnant individuals, and patients who can't stop antihistamines or prednisone are excluded.

Inclusion Criteria

You have had a bad reaction to the drug in the past, either during a test or based on your medical history.

You have had an allergic reaction to shellfish in the past.

Exclusion Criteria

I am currently taking beta-blocker medications.

I have had a stroke or have severe narrowing of my neck arteries.

I have severe asthma or obstructive lung disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1: Skin Test

Participants undergo a skin prick test and IgE analysis for shellfish allergy. Novapak is applied to the skin for 30 minutes, followed by 1-hour monitoring for allergic reactions.

1 day

1 visit (in-person)

Stage 2: Nasal Application

If no allergic symptoms are observed in Stage 1, Novapak is applied to the nasal cavity for 15 minutes, followed by 1-hour monitoring for allergic reactions.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for allergic reactions and changes in nasal congestion score 48 hours after the nasal application.

48 hours

What Are the Treatments Tested in This Trial?

Interventions

• NOVAPAK Nasal Packing

Trial Overview The study tests the safety of NOVAPAK nasal packing in people allergic to shellfish. NOVAPAK will be applied both on the forearm and inside the nasal cavity to see if it's safe for use after nosebleeds or surgery despite its shellfish-derived materials.

How Is the Trial Designed?

Group I: Study arm Experimental Treatment 2 Interventions

Stage 1 After shellfish allergy is confirmed through the skin prick test and IgE analysis, Novapak packing will be applied to the patient's skin for 30 minutes on the anterior aspect of the patients' non-dominant arm. In case of pre-existing wounds, it will be applied to the other forearm. Participants will then be monitored for 1 hour, and any- reaction will be documented. In case of any symptoms of an allergic reaction, their study participation will be terminated. Stage 2 If no allergic symptoms are observed in stage 1, the patient's nose will be anesthetized with topical lidocaine. A piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes. After removal, the participant will be monitored in the clinic for an hour. Any allergic reaction will be documented, including increased nasal congestion, rhinorrhea, or pruritis.

Who Is Running the Clinical Trial?

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Citations

1. trials.foodallergy.org trials.foodallergy.org/trials/NCT05343650

NOVAPAK Nasal Packing in Shellfish Allergic Patients Since Novapak contains purified chitosan, the investigators hypothesizes that no allergic reactions will be demonstrated. Arms & Interventions. Arms.

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/14/NCT05747014/Prot_000.pdf

Novapak Prospective Observational ... This study is being conducted to support the safety and treatment effectiveness profile of the Medtronic. Novapak Nasal Sinus Packing and Stent ...

3. ctv.veeva.com ctv.veeva.com/study/novapak-prospective-observational-clinical-trial

Novapak Prospective Observational Clinical Trial The primary objective is to assess the safety of the Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively in patients ...

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05343650?keyword=%22Epistaxis%22

NOVAPAK Nasal Packing in Shellfish Allergic Patients This is a prospective interventional study to assess whether the tested product triggers an allergic reaction in patients with known-shellfish allergies.

5. medtronic.com medtronic.com/en-us/healthcare-professionals/products/ear-nose-throat/post-operative/nasal-packing/novapak-nasal-sinus-packing-and-stent.html

Novapak™ Nasal Sinus Packing and Stent Novapak™ nasal sinus packing and stent contains chitosan from shellfish and should not be used in patients with known allergic responses to shellfish. For ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05747014/novapak-prospective-observational-clinical-trial

Novapak Prospective Observational Clinical Trial The primary objective is to assess the safety of the Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively in patients ...

7. aging.networkofcare.org aging.networkofcare.org/riverside/CommunityResources/ClinicalTrials/Detail/NCT05343650?keyword=%22Epistaxis%22

NOVAPAK Nasal Packing in Shellfish Allergic Patients This is a prospective interventional study to assess whether the tested product triggers an allergic reaction in patients with known-shellfish allergies.