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

Trial Summary

What is the purpose of this trial?

NOVAPAK is a sponge-like material made from materials found in shellfish. It is commonly used after nasal surgery or in nasal bleeding, as it promotes healing, decreases bleeding, and has antibacterial properties. Although NOVOPAK does not contain proteins or compounds known to be responsible for allergic reactions in people with a known allergy to shellfish, out of an abundance of caution, the manufacturer (Medtronic) has recommended avoidance in those with known shellfish allergy. There have been no reported allergic reactions in patients with shellfish allergy who were given chitosan bandages in emergencies (e.g. military applications). The study aims to investigate the safety of its use in patients with known shellfish allergy to improve healthcare quality and patient care support.

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.

How does the NOVAPAK Nasal Packing treatment for shellfish allergy differ from other treatments?

The NOVAPAK Nasal Packing treatment is unique because it is administered through the nasal route, which is different from typical oral or injectable allergy treatments. This method may offer a novel way to manage shellfish allergies by potentially reducing allergen exposure through the nasal passages. ^{1 2 3 4 5}

Eligibility Criteria

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

I am between 18 and 60 years old.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Immunoadjuvant properties of glove cornstarch powder in latex-induced hypersensitivity. [2019]

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

Prevalence of food allergy in 137 latex-allergic patients. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Inhaled cornstarch glove powder increases latex-induced airway hyper-sensitivity in guinea-pigs. [2006]

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

Latex allergy--a clinical perspective. [2005]

5. Poland pubmed.ncbi.nlm.nih.gov

Latex allergy. [2004]