Intranasal Capsaicinoid Spray for Allergic Rhinitis

Overseen By S Mark Taylor, MD FRCSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Under 18, Pregnancy, Nasal surgery, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a nasal spray made from capsaicin, a natural ingredient in hot peppers, might help with allergic rhinitis. Rhinitis causes itchiness, sneezing, and a runny nose, and current treatments often fall short. The study aims to find the safest dose of capsaicin that reduces these symptoms without causing excessive discomfort, such as a burning sensation or extra tearing. Healthy adults without previous nasal surgery or pepper allergies are suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatment options for allergic rhinitis.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intranasal capsaicinoid spray is safe for treating rhinitis?

Research has shown that an intranasal capsaicin spray is generally safe for people with rhinitis. Studies have found that this treatment quickly and safely improves symptoms for those suffering from rhinitis. In one study, no major safety issues were reported, and patients responded well to the spray.

However, capsaicin can cause a burning sensation in the nose. Some people might also experience a runny nose or watery eyes after using the spray. These reactions are common but usually mild.

Overall, while the treatment appears safe, it might cause some temporary discomfort. Consider personal tolerance and discuss any concerns with a healthcare provider when considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for allergic rhinitis, which often include antihistamines and nasal corticosteroids, the intranasal capsaicinoid spray introduces a unique approach by utilizing capsaicin. Capsaicin, the spicy component found in chili peppers, works by desensitizing nasal sensory neurons, which can help reduce symptoms like congestion and sneezing. Researchers are excited about this treatment because it could offer a natural alternative with potentially fewer side effects and quicker symptom relief compared to traditional medications. Additionally, the spray format allows for direct application to the nasal passages, targeting the source of symptoms more effectively.

What evidence suggests that intranasal capsaicinoid spray might be an effective treatment for allergic rhinitis?

Research has shown that a nasal spray containing capsaicin can reduce symptoms of rhinitis, such as sneezing and a stuffy nose. One study found that people who used the spray for two weeks experienced significant improvement in symptoms, including reduced congestion and sinus pressure. Another study demonstrated that the spray provided quick and lasting relief from these symptoms. Capsaicin works by blocking certain pathways in the nose, making it less sensitive and reducing symptoms like a runny nose. Overall, these findings suggest that capsaicin spray can be an effective option for those dealing with persistent rhinitis symptoms. Participants in this trial will receive escalating doses of intranasal capsaicinoid spray to further evaluate its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

S Mark Taylor, MD FRCSC

Principal Investigator

Dalhousie University

David WA Forner, MD

Principal Investigator

Dalhousie University

Are You a Good Fit for This Trial?

This trial is for healthy adults with rhinitis, which causes a runny nose, sneezing, and itchiness. Participants must be in good health as defined by the American Association of Anesthesiology Class 1.

Inclusion Criteria

American Association of Anesthesiology Class 1,"A normal, healthy patient" only

I am a healthy adult.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of intranasal capsaicinoid spray to determine tolerability and side effect profile

1 week

Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of rhinorrhea, pain, and lacrimation

1 week

2 visits (1 hour and 1 week post-treatment)

What Are the Treatments Tested in This Trial?

Interventions

• Intranasal Capsaicinoid Spray

Trial Overview The study tests an intranasal capsaicinoid spray to see if it can reduce rhinitis symptoms. It aims to find the safest dose that minimizes discomfort from its known burning sensation and other reactions.

How Is the Trial Designed?

Group I: Intranasal Capsaicin Experimental Treatment 1 Intervention

Separate patients will be given escalating doses of intranasal capsaicinoid spray

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03952845

NCT03952845 | Intranasal Capsaicinoid Spray This natural product has been used as a lotion to prevent pain, and scientists have found that it may reduce the symptoms of rhinitis when used as a spray in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8209653/

A randomized, double-blind, parallel trial comparing ... This study demonstrated that continuous treatment with ICX7 (Sinus Buster) over 2 weeks significantly improved TNSS, nasal congestion, sinus pressure, sinus ...

3. clinicaltrial.be clinicaltrial.be/en/details/63645?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Intranasal Capsaicinoid Spray Blocking this pathway results in decreased nasal hypersensitivity and leads to reduced nasal obstruction, sneezing, and rhinorrhea.

4. jacionline.org jacionline.org/article/S0091-6749(18)31935-3/fulltext

Capsaicin Nasal Spray Showed Significant And Rapid ... Capsaicin Nasal Spray showed significant rapid and sustainable relief in overall composite symptom scores of TNSS. The Nasal Spray was generally well-tolerated ...

5. med.uth.edu med.uth.edu/orl/2022/02/01/trial-results-show-benefits-of-intranasal-capsaicin-for-patients-with-nonallergic-rhinitis/

Trial Results Show Benefits of Intranasal Capsaicin for ... Capsaicin also objectively reduced nasal reactivity and nasal congestion with a 40 percent rate of response at 12 weeks using ORM for evaluation ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0954611122000373

Therapeutic applications of capsaicin in humans to target ... Seventeen studies reported positive effects of capsaicin on clinical outcomes for rhinitis, nasal polyposis, chronic cough, and pneumonia. Sixteen studies ...

7. aafp.org aafp.org/pubs/afp/issues/2016/0801/p217.html

Capsaicin for Nonallergic Rhinitis Intranasal capsaicin is safe and effective for reducing symptoms of nonallergic rhinitis (number needed to treat = 4; 95% confidence interval [CI], 1 to 22).