A Double-blind, Randomized, Parallel-group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators), in Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis (SAR)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,111
- 试验地点
- 10
- 主要终点
- Change in rTNSS From Baseline to End of Treatment
研究概览
简要总结
Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥12 years and older inclusive of either sex.
- •Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the study season for the mountain cedar pollen
- •A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).
排除标准
- •Pregnant or lactating women.
- •Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period.
- •History of nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa.
- •History of anaphylaxis and/or other severe local reaction(s) to skin testing.
- •History of positive test for HIV, Hepatitis B or Hepatitis C infection.
- •Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
- •Subjects with an active pulmonary disorder or infection.
- •Subjects with posterior subcapsular cataracts or glaucoma.
研究组 & 干预措施
GSP 301 Placebo NS
干预措施: GSP 301 Placebo NS (Drug)
GSP 301-1 NS (QD)
干预措施: GSP 301-1 NS (QD) (Drug)
GSP 301-2 NS (BID)
干预措施: GSP 301-2 NS (BID) (Drug)
Olopatadine HCl-1 NS (QD)
干预措施: Olopatadine HCl-1 NS (QD) (Drug)
Olopatadine HCl-2 NS (BID)
干预措施: Olopatadine HCl-2 NS (BID) (Drug)
Mometasone Furoate-1 NS (QD)
干预措施: Mometasone Furoate-1 NS (QD) (Drug)
Mometasone Furoate-2 NS (BID)
干预措施: Mometasone Furoate-2 NS (BID) (Drug)
结局指标
主要结局
Change in rTNSS From Baseline to End of Treatment
时间窗: 14 days
Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching. The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome. The severity scale for each symptom evaluation was defined as follows: * 0 = absent (no sign/symptom evident) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate \[i.e., causes interference with activities of daily living and/or sleeping\])
次要结局
未报告次要终点