This study is a phase III clinical study to assess the efficacy and safety of Dymista® Nasal Spray in comparison to Azep® nasal spray and Flixonase® nasal spray in Chinese patients aged ≥ 12 years with moderate-to-severe allergic rhinitis/rhinoconjunctivitis.
This is a multicentre, randomized, active controlled prospective clinical trial in adult and adolescent patients with AR (seasonal and/or perennial), who have moderate-to-severe symptoms (rhinitis/ rhinoconjunctivitis), based on the Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 Guidelines. The study consists of a 3 to 7-day Lead-in Period during which patients must meet a minimum symptom severity score to be eligible for the Treatment Period. All patients will start the Lead-in Period straight after Screening Visit as soon as in/exclusion criteria are fulfilled. The Lead-in Period will be followed by a 14-day double-blind Treatment Period. At some time point during the study, patients will receive Placebo and Dymista® nasal spray or Azep® nasal spray or Flixonase® nasal spray, 1 spray per nostril twice daily according to randomization. On the first day of the Lead-in Period patients must meet study inclusion/exclusion criteria and have a sufficient AR symptom score to qualify for entry. Qualified patients will be requested to keep a Diary of nasal and ocular symptoms throughout the study period. Additionally, patients will be requested to complete the Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and EuroQoL 5D questionnaire (EQ-5D) on Day 1, Day 8 and Day 15. Both Questionnaires will be completed by adult patients only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
900
Dymista Nasal spray suspension
AZEP Nasal spray solution
Fluticasone propionate nasal spray suspension
Combined 12-hour rTNSS (AM + PM)
Total nasal symptom score (TNSSS) is a sum of 4 individual nasal symptom scores: nasal itching, runny nose, congestion and sneezing. Each nasal symptom will be assessed according to a 4-ponit scale (0 = no, 1 = mild, 2 = moderate, 3 = severe symptom); thus, each TNSS will be in the range from 0 (no symptoms at all) to 12 (all 4 symptoms are severe) and the combined 12-hour reflective TNSS (morning + evening) will be in the range of 0 to 24 accordingly
Time frame: 14 days
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Investigational Site 2
Beijing, Beijing Municipality, China
Investigational Site 3
Beijing, Beijing Municipality, China
Investigational Site 4
Beijing, Beijing Municipality, China
Investigational Site 5
Beijing, Beijing Municipality, China
Investigational Site
Chongqing, Chonqing, China
Investigational Site 1
Beijing, Dongcheng District, China
Investigational Site 1
Guangzhou, Guangdong, China
Investigational Site 2
Guangzhou, Guangdong, China
Investigational Site 1
Wuhan, Hubei, China
Investigational Site 2
Wuhan, Hubei, China
...and 23 more locations