EUCTR2004-004749-17-DK进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, 2-week crossover, knemometricassessment of the effect of once daily GW685698X Aqueous Nasal Spray 100 mcgon short term growth in children ages 6 - 11 years with seasonal and/or perennialallergic rhinitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteria
- •Pre-menarcheal female subjects who are 6 years to less than 11 years of age at
- •the time of randomization
- •Male subjects who are 6 years to less than 12 years of age at the time of
- •randomization
- •Tanner Stage 1
- •Documented clinical history of SAR or PAR of at least one year prior to study entry
- •with (in the opinion of the investigator):
- •- a current level of allergic rhinitis symptoms that warrant treatment with an
- •intranasal corticosteroid and/or
- •- expected symptoms during a majority of the study period
- •Diagnosis must be confirmed by a positive skin test (by skin prick method) to an
- •appropriate seasonal or perennial allergen within 12 months prior to Visit 1 or at
- •Visit 1. A positive skin test is defined as a wheal > or equal to 3 mm larger than
- •the diluent control for prick testing.
- •In vitro tests for specific IgE (such as RAST, PRIST) will also be permitted as
- •confirmation for a diagnosis of SAR or PAR if performed within the last 12 months
- •or at Visit 1.
- •Normal current growth as reflected by baseline height within the 5th and 95th
- •percentiles of normal for their age and gender as determined by stadiometry and
- •Danish longitudinal standard charts
- •Subjects must be willing and able to comply with study procedures
- •Written informed consent must be provided by the parent or guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A subject will not be eligible for inclusion in this study if any of the following criteria
- •History of abnormal growth or gross malnutrition
- •Findings of a clinically significant laboratory abnormality (Section 6.4.4)
- •History of any condition that may have substantially affected growth
- •Subjects with historical or current evidence of clinically significant, uncontrolled
- •disease of any body system (in addition to allergic rhinitis), such as uncontrolled,
- •epilepsy, active tuberculosis, attention deficit hyperactive disorder, psychological
- •disorders or eczema, will not be eligible. Significant is defined as any disease that,
- •in the opinion of the investigator, would put the safety of the subject at risk
- •through study participation or which would confound the interpretation of the
- •study results if the disease/condition exacerbated during the study
- •Any asthma other than mild, intermittent asthma controlled by short-acting, ß-
- •agonists [Global Initiative for Asthma (GINA) Guidelines, 2003]
- •Recent major surgery and/or trauma to the legs
- •Current or history of glaucoma and/or cataracts or ocular herpes simplex
- •History of adrenal insufficiency
- •Current or prior treatment with any medication that may have a potential for an
- •ongoing effect on linear growth
- •Use of corticosteroids, defined as Any corticosteroid use by any route within 4
- •weeks prior to Visit 1
- •Any nasal condition or deformity that would impair nasal breathing or deposition of
- •medication (i.e., nasal polyps, marked septal deviation)
- •Physical impairment that would affect the subject’s ability to participate in the study
- •Documented evidence of acute or significant chronic sinusitis
- •Upper or lower respiratory or sinus infection during the 7 days before screening
- •Clinical evidence of a nasal or oropharyngeal Candida infection
- •Rhinitis medicamentosa
- •Severe dehydration
- •Use of any medications that significantly inhibit the cytochrome P450 subfamily
- •enzyme CYP3A4, including ritonavir and ketoconazole
- •Subjects with known hypersensitivity to any excipients in the study medications
- •Previous clinical trial experience with GW685698X aqueous nasal spray
- •Exposure to clinical trial/experimental medication within 30 days of Visit 1
- •Affiliation with investigational site such that the subject is an immediate family
- •member of any site personnel
- •Chickenpox or measles infections - A subject is not eligible if he/she currently has
- •chickenpox or measles, or has been exposed to chickenpox or measles during the
- •last 3 weeks and is non-immune.
研究者
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