None listed
Conditions
Brief 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.
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.
Sponsors
Metro North Hospital and Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed