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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the intranasal capsaicinoid spray treatment for allergic rhinitis?

Research shows that capsaicin, the active ingredient in the spray, can reduce symptoms in people with allergic rhinitis when used in the nose. It has also been effective in treating other types of nasal conditions, like vasomotor rhinitis, by reducing symptoms such as nasal obstruction and secretion. ^{1 2 3 4 5}

Is intranasal capsaicin spray safe for humans?

Intranasal capsaicin spray has been studied for various types of rhinitis and is generally considered safe, though it can cause a painful sensation and nasal fluid secretion initially. These effects tend to diminish with continued use. ^{2 3 5 6 7}

How does the drug Intranasal Capsaicinoid Spray differ from other treatments for allergic rhinitis?

Intranasal Capsaicinoid Spray is unique because it uses capsaicin, the active component in hot peppers, to target sensory nerves in the nasal passages, potentially reducing symptoms by blocking nerve reflexes. This approach is different from typical treatments that often focus on reducing inflammation or blocking histamines. ^{1 4 5 8 9}

What is the purpose of this trial?

Rhinitis is inflammation of the inside of the nose. Symptoms of rhinitis include itchiness, sneezing, and a "runny" nose (rhinorrhea). There are many different causes for rhinitis, including allergies, age, different irritants in the air, overacting nervous system, and others. Many current treatments for rhinitis are not helpful or are unable to be used for long periods of time. Capsaicin ("Kap-Sey-Uh-Sin") is a natural product that is found in many spicy foods, including hot peppers. 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 the nose. However, capsaicin is known to cause a burning sensation. This study is needed so we can figure out what doses of capsaicin cause this burning sensation, and to what level these doses cause discomfort. Capsaicin can also cause a small degree of tearing from the eyes when used as a spray in the nose, and can also cause the nose to become "runny" (rhinorrhea). When the safest dose of capsaicin spray is found, that dose can be used to treat people with rhinitis that is not getting better from standard treatments.

Research Team

S Mark Taylor, MD FRCSC

Principal Investigator

Dalhousie University

David WA Forner, MD

Principal Investigator

Dalhousie University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Therapeutic effect of capsaicin nasal treatment in patients with mixed rhinitis unresponsive to intranasal steroids. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Capsaicin desensitization of the nasal mucosa reduces symptoms upon allergen challenge in patients with allergic rhinitis. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Beneficial effects of intranasal applications of capsaicin in patients with vasomotor rhinitis. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of perennial non-allergic rhinopathy with capsaicin]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Intranasal capsaicin is efficacious in non-allergic, non-infectious perennial rhinitis. A placebo-controlled study. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Intranasal Capsicum spray in idiopathic rhinitis: a randomized prospective application regimen trial. [2013]

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

Pharmacotherapy for allergic rhinitis. [2013]

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

Intranasal spray medications for maintenance therapy of allergic rhinitis. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Capsaicin for allergic rhinitis in adults. [2023]