This is a Phase 2a study to evaluate the efficacy and safety of Norketotifen (NKT) in subjects with allergic rhinitis.
This is a single-center, double-blind, randomized, placebo-controlled, 3-way crossover study evaluating the efficacy and safety of NKT in adult subjects with allergen-induced allergic rhinitis in an allergen challenge chamber.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Norketotifen oral capsule
Placebo oral capsule
Biogenics Research Chamber
San Antonio, Texas, United States
Change in Total Nasal Symptom Score (TNSS) from pre-dose to 6 hours post-dose
Change in TNSS from pre-dose to 6 hours post-dose for NKT vs placebo. The TNSS is the sum of the scores of four nasal symptoms (runny nose, congestion, itching, and sneezing) each scored on a scale of 0 to 3 (0=absent; 1=mild; 2=moderate; 3=severe). The TNSS score ranges from 0 to 12.
Time frame: 6 hours
Change in Total Ocular Symptom Score (TOSS) from pre-dose to 6 hours post-dose
Change in TOSS from pre-dose to 6 hours post-dose for NKT vs placebo. The TOSS is the sum of the scores of three ocular symptoms (itching, tearing, and redness) each scored on a scale of 0 to 3 (0=absent; 1=mild; 2=moderate; 3=severe). The TOSS score ranges from 0 to 9.
Time frame: 6 hours
Change in Total Symptom Score (TSS) from pre-dose to 6 hours post-dose
Change in TSS from pre-dose to 6 hours post-dose for NKT vs placebo. The TSS is the sum of the TNSS and TOSS (described above) and ranges from 0 to 21.
Time frame: 6 hours
Area under the curve (AUC) of TNSS over 6 hours post-dose
AUC of TNSS over 6 hours post-dose for NKT vs placebo
Time frame: 6 hours
AUC of TOSS over 6 hours post-dose
AUC of TOSS over 6 hours post-dose for NKT vs placebo
Time frame: 6 hours
AUC of TSS over 6 hours post-dose
AUC of TSS over 6 hours post-dose for NKT vs placebo
Time frame: 6 hours
Change in individual nasal symptoms from pre-dose to 6 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in individual nasal symptoms from pre-dose to 6 hours post-dose for NKT vs placebo
Time frame: 6 hours
Change in individual ocular symptoms from pre-dose to 6 hours post-dose
Change in individual ocular symptoms from pre-dose to 6 hours post-dose for NKT vs placebo
Time frame: 6 hours