Double-Blind Study to Evaluate the Safety and Efficacy of RT001 Gel and Placebo for Treatment of Allergic Rhinitis
- Conditions
- Allergic rhinitisInflammatory and Immune System - Allergies
- Registration Number
- ACTRN12612001093875
- Lead Sponsor
- INC Research Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 70
Seasonal allergic rhinitis reactive to rye grass allergen on skin prick test
Total nasal symptom score of at least 7 (scale 0-12)
Nasal disease such as sinusitis, polyps, or nasal structural abnormalities likely to affect application of medication
Bacterial or viral infection within 14 days of screening
Nasal surgery within 1 year
Active asthma requiring medication more than 3 times per week or significant pulmonary disease within 1 year
Frequent use of high doses of anti-inflammatory drugs within 2 weeks of treatment or antibiotics within 4 weeks
Current use of aminoglycoside or other agents that might interfere with neuromuscular transmission
Previous treatment with botulinum toxin or history of botulism
Neurological condition that might place subject at increased risk with exposure to Botulinum Toxin Type A
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in Total Nasal Symptom score for RT001 versus placebo. The Total Nasal Symptom Score is the sum of 4 individual participant-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each rated on a 4-point scale of none to severe.[Baseline, Week 4]
- Secondary Outcome Measures
Name Time Method Individual nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, are each rated by the subject on a 4-point scale of none to severe.[Baseline, Week 2, Week 4, Week 8];Rhinoconjuntivitis Quality of Life Questionnaire (RQLQ)[Baseline, Week 2, Week 4, Week 8];Peak Nasal Inspiratory Flow (PNIF) and Peak Expiratory Flow (PEF) as measured by flow meters[Baseline, Week 2, Week 4, Week 8];Safety assessments include safety labs, local irritation at gel application site, cranial nerve evaluations, adverse events and concomitant medication use.[Baseline and follow-up visits at Day 2, Week 2, Week 4 and Week 8]