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

Phase 1

• Conditions: Allergic Rhinitis; Non-Allergic Rhinitis; Inflammatory and Immune System - Allergies; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12624000772549
• Lead Sponsor: Metro North Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-25
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

1. Patients less than 18 years
2. Participants who are unable to provide informed consent.
3. Participants who are pregnant, breast feeding or planning to become pregnant during study.
4. Participants with an absolute contraindication to botulinum toxin type A specifically allergy, pregnancy, coexisting myasthenia gravis.
5. Coexisting chronic rhinosinusitis.
6. Subjects with known hypersensitivity or contraindications to mometasone nasal spray.
7. Participants who have been on an active investigational therapy within 1 month prior to screening
8. 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
9. Currently on any medication that may affect the results in an unpredictable manner.
10. The participant does not agree to comply with or is unable to meet all study requirements for the duration of the study period.
11. Participants deemed by the investigator to be unsuitable for participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total nasal symptom scores[Total Nasal Symptom score (TNSS) Baseline (day 0), 2 Weeks post-baseline and 4 Weeks post-baseline]

Secondary Outcome Measures

Name	Time	Method
Overall symptom change measured on Visual Analogue scale [VAS (Visual Analogue Scale ) Baseline (Day 0), 2 weeks post-baseline and 4 weeks post-baseline];Peak Nasal Inspiratory Flow changes[Peak Nasal Inspiratory Flow (PNIF) measurements Baseline (Day 0) and 4 weeks post-baseline];Nasal Endoscopy Changes[Nasal Endoscopy observation of Nasal Mucosa changes Baseline (Day 0) and 4 weeks post-baseline];Adverse Events records[Reporting of Adverse medical events or complications of treatment recorded on Adverse event forms and reviewed by study investigators.<br>Possible adverse events are Epistaxis ( Nose bleed), Nasal dryness, Nasal Irritation . <br> From signing of consent to end of study]