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 intra nasal 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. The overall aim of this study is to investigate the efficacy and safety of topical intranasal botulinum toxin type A in the treatment of refractory rhinitis when compared with a placebo.
Interventions
The intervention treatment is Botulinum toxin type A (BTA) which will be reconstituted with Fresenius Kabi sterile 0.9% sodium chloride injection BP in the correct dilutional ratio. The reconstituted solution will be administered topically into each nostril using a mucosal atomisation device (LMA® MAD Nasal™). Each participant will receive a total of 40units (20 units per nostril) administered as 0.4ml/nostril of intra-nasal BTA or placebo given as a one-off dose at Baseline visit. The administr
The intervention treatment is Botulinum toxin type A (BTA) which will be reconstituted with Fresenius Kabi sterile 0.9% sodium chloride injection BP in the correct dilutional ratio. The reconstituted solution will be administered topically into each nostril using a mucosal atomisation device (LMA® MAD Nasal™). Each participant will receive a total of 40units (20 units per nostril) administered as 0.4ml/nostril of intra-nasal BTA or placebo given as a one-off dose at Baseline visit. The administration of the dose will be given by a medical investigator after an examination of the nostril. The administration will take approximately one minute per nostril The patient will then be monitored for 15 mins after the procedure to observe for any adverse reaction. The volume in each syringe is 0.4ml prior to administration. This volume will be checked and recorded on a drug accountability form. The syringe will be checked after administration, if there is anything left in the syringe this will be recorded on the accountability log as will any syringe that is not administered e.g. if the patient has a reaction to the first syringe, then the second one would not be administered.
Sponsors
Metro North Hospital and Health Services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each patient must meet all of the following criteria to be enrolled in this trial: 1. Patients greater than or equal to 18 years old 2. Clinically confirmed diagnosis of allergic or non-allergic rhinitis. 3. Prior radioallergosorbent (RAST) test and 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
Participants meeting any of the following criteria will be excluded from the trial: 1. Patients less than or equal to 17 years old 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 IUD or similar and Condoms. 9. The participant does not agree to comply with or is unable to meet all study requirements for the duration of the study period. 10. Participants deemed by the investigator to be unsuitable for participation in the study.
Outcome results
None listed