NCT01622231已完成3 期
Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
研究概览
简要总结
Safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis will be evaluated. And secondarily, efficacy and systemic exposure of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent
- •2 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
- •Six months 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 >= 3.0 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.
- •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)
结局指标
主要结局
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)
时间窗: From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an other important medical event, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold \>=5%) and SAEs.
次要结局
- Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal(Baseline, Week 4, and Week 12/Early Withdrawal)
- Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal(Baseline, Week 4, and Week 12/Early Withdrawal)
- Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal(Baseline, Week 4, and Week 12/Early Withdrawal)
- Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal(Baseline, Week 4, and Week 12/Early Withdrawal)
- Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal(Baseline, Week 4, and Week 12/Early Withdrawal)
- Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal(Baseline, Week 4, and Week 12/Early Withdrawal)
- Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal(Baseline, Week 4, and Week 12/Early Withdrawal)
- Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal(Baseline, Week 4, and Week 12/Early Withdrawal)
- Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal(Baseline, Week 4, and Week 12/Early Withdrawal)
- Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12(Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12)
- Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12(Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12)
- Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS)(Baseline, Day 1 to Day 84)
- Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12(Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12)
- Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12(Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12)
- Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12(Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12)
- Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12(Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12)
- Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12(Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12)
- Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12(Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12)
- Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12(Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12)
- 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)(Baseline, Week 4, Week 8, and Week 12/early withdrawal)
- Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator(Week 12/early withdrawal)
- Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant(Week 12/early withdrawal)
- Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years(Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5))
- Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years(Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5))
研究者
研究点 (1)
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