NCT01630135已完成3 期
Study FFR116364, a Double-blind, Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period
研究概览
简要总结
Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in Japanese paediatric subjects ages 6 to < 15 years with perennial allergic rhinitis will be evaluated compared with placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent
- •6 to <15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient
- •Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit
- •One year or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A.
- •Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study.
- •ALT < 2xULN; alkaline phosphatase and bilirubin <= 1.5xULN
- •Average of 3TNSS is >= 4.0 in the last consecutive 4 days prior to Visit
- •Completion of the patient diary on >= 3 days of the last consecutive 4 days prior to Visit 2
排除标准
- •Has a seasonal pollen as an allergen
- •A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1)
- •Bacterial or viral infection of upper respiratory tract or eye
- •Concurrent disease/abnormalities: Clinically significant uncontrolled disease
- •Known hypersensitivity to corticosteroids or any excipients in the investigational product
- •Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1
- •Use of the following medication and/or its combination drug within the specified time:
- •Anti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1
- •Affiliation with Investigator's Site: Relative or employee
- •History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study.
- •Average of 3TNSS is >= 8.0 in the last consecutive 4 days prior to Visit
- •Bacterial or viral infection of upper respiratory tract or eye during the screening period.
研究组 & 干预措施
GW685698X
Experimental
GW685698X 55mcg/day
干预措施: Fluticasone furoate (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period
时间窗: Baseline through the entire treatment period (2 weeks)
The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.
次要结局
- Mean Change From Baseline in 3TNSS at Week 1 and Week 2(Baseline; Week 1 and Week 2)
- Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2(Baseline through the entire treatment period (2 weeks), Week 1, and Week 2)
- Mean Change From Baseline in 3TNSS at the Indicated Days(Baseline; Days 1 through 14)
- Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2(Baseline through the entire treatment period (2 weeks), Week 1, and Week 2)
- Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2(Baseline through the entire treatment period (2 weeks), Week 1, and Week 2)
- Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2(Baseline through the entire treatment period (2 weeks), Week 1, and Week 2)
- Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2(Baseline through the entire treatment period (2 weeks), Week 1, and Week 2)
- Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2(Baseline through the entire treatment period (2 weeks), Week 1, and Week 2)
- Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2(Baseline through the entire treatment period (2 weeks), Week 1, and Week 2)
- Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2(Baseline through the entire treatment period (2 weeks), Week 1, and Week 2)
- Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2(Baseline through the entire treatment period (2 weeks), Week 1, and Week 2)
- Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2(Baseline through the entire treatment period (2 weeks), Week 1, and Week 2)
- Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW(Baseline, Week 1, and Week 2/Early Withdrawal (EW))
- Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator(Week 2/EW)
- Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant(Week 2/EW)
研究者
研究点 (1)
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