Not Yet RecruitingPhase 1ACTRN12624000772549

A pilot study to evaluate the effectiveness of intranasal Botulinum Toxin Type A Spray for patients with Rhinitis

A pilot study to evaluate the effectiveness of intranasal Botulinum Toxin Type A Spray for adult patients with Rhinitis

Sponsor

Metro North Hospital and Health Service

Enrollment

15 participants

Start Date

Jul 10, 2024

Study Type

Interventional

Conditions

Allergic Rhinitis

Summary

Rhinitis affects approximately 20 to 40% of the population and is currently poorly controlled in approximately 15% of the population with standard treatment. Botulinum toxin type A spray could provide a painless, easily applied and potentially alternate treatment for sufferers. Currently there is wide use in cosmetic clinics but few supporting clinical trials. . HYPOTHESIS We aim to test the hypothesis that botulinum toxin type A is an effective treatment for rhinitis when delivered via intranasal spray, as measured by total nasal symptom score. INTERVENTION 40 units Botulinum toxin type A administered topically intranasally using the LMA® MAD Nasal™ Intranasal Mucosal Atomization Device by Teleflex (ARTG number 294634). 20 units will be administered per nostril at the base line visit of the study.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

Patients greater than or equal to 18 years
Clinically confirmed diagnosis of allergic or non-allergic rhinitis.
Prior Radioallergosorbent test (RAST) test and immunoglobulin E ( IgE) level (as part of the patient’s standardised medical treatment).
Incomplete management of symptoms despite appropriate medical treatment (intra-nasal corticosteroid and nasal douching)

Exclusion Criteria13

Patients less than 18 years
Participants who are unable to provide informed consent.
Participants who are pregnant, breast feeding or planning to become pregnant during study.
Participants with an absolute contraindication to botulinum toxin type A specifically allergy, pregnancy, coexisting myasthenia gravis.
Coexisting chronic rhinosinusitis.
Subjects with known hypersensitivity or contraindications to mometasone nasal spray.
Participants who have been on an active investigational therapy within 1 month prior to screening
Women of childbearing potential who are not willing to use double barrier method of contraception during the study. That is:
Use of contraceptive pill or intrauterine device (IUD) or similar
and Condoms
Currently on any medication that may affect the results in an unpredictable manner.
The participant does not agree to comply with or is unable to meet all study requirements for the duration of the study period.
Participants deemed by the investigator to be unsuitable for participation in the study.

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Interventions

40 units Botulinum toxin type A administered topically intranasally using a mucosal atomisation device. 20 units will be administered per nostril. This is a Once only dose administered by study investigator in ENT clinic at Baseline (day 0). The details of the dose will be documented on the patient case report form including check for correct dose and check that complete dose is administered.