Effects of Botulinum toxin A addition to allergen specific immunotherapy for treating Allergic Rhinitis
Phase 1
- Conditions
- patients with allergic rhinitis, age between 18-60 years oldBotulinum toxins A, Immunotherapy, Allergic Rhinitis, Vasomotor Rhinitis
- Registration Number
- TCTR20220914004
- Lead Sponsor
- Faculty of Medicine of Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
1. Patient diagnosed as allergic rhinitis by clinical symptoms and confirmed by skin prick test according to ARIA guideline.
2. Age 18 years to 60 years
3. Failed to conventional pharmacological treatment (patients still have moderate to severe symptoms according to ARIA guideline or VAS at least 5)
4. Currently on immunotherapy at the maintenance dose
Exclusion Criteria
1 Pregnancy
2 Acute or chronic rhinosinusitis
3 Previous allergy to Botox or local anesthetic agents
4 Underlying neuromuscular disorders e.g. myasthenia gravis
5 On any anti-allergic drugs within 2 weeks prior to study
6 Prior nasal surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method nasal symtoms and quality of life at 4 and 8 week after intervention individual and total nasal symptoms score, RCQ-36
- Secondary Outcome Measures
Name Time Method adverse events at day 0, 4 and 8 week after intervention report