EUCTR2004-004744-43-NO进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Vasomotor/Idiopathic Rhinitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 347
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
入选标准
- •Subject will be eligible for inclusion only if all of following criteria apply:
- •1. Informed consent
- •Subject has provided an appropriately signed and dated informed consent. An
- •appropriately signed and dated assent must be obtained from the parents or
- •guardian if the subject is a child under 18 years of age.
- •2. Subject is treatable on an outpatient basis.
- •3. Age - = 12 years at Visit 2
- •4. Male or eligible female
- •To be eligible for entry, females of childbearing potential must commit
- •to consistent and correct use of an acceptable method of birth control, as defined
- •by the following:
- •Male partner who is sterile prior to the female subject’s entry into study and
- •is sole sexual partner for that female subject
- •Implants of levonorgestrel
- •Injectable progestogen
- •Oral contraceptive (either combined estrogen/progestin or progestin only)
- •Any intrauterine device (IUD) with a documented failure rate of less than 1%
- •per year, or
- •Females of childbearing potential who are not sexually active must commit to
- •complete abstinence from intercourse for 2weeks before exposure to the
- •study drug, throughout the clinical trial, and for a period after the trial to account
- •for elimination of the drug (minimum of six days).
- •Double barrier method – spermacide plus a mechanical barrier (e.g., spermacide
- •plus a male condom or a spermacide and female diaphragm).
- •Female subjects should not be enrolled if they plan to become pregnant during the
- •time of study participation. A serum pregnancy test will be performed at screening
- •visit and final/early withdrawal visit. A urine pregnancy test will be performed at
- •randomization visit (Visit 2) and Visit 4.
- •5. Diagnosis of VMR/IR to include ALL of the following:
- •a Two year clinical history of VMR/IR (written or verbal confirmation) and
- •evidence to support the perennial nature of the disorder and its potential
- •fluctuation with weather conditions, such as, seasonal changes, abrupt changes
- •in temperature, weather fronts, and variations in humidity, along with symptoms
- •provoked by respiratory irritant exposure (e.g., tobacco smoke, perfumes, paint
- •fumes). VMR/IR chronic symptoms would include rhinorrhea, nasal congestion
- •and postnasal drip.
- •b Subjects must have checked at least 3 of the Inhaled/Strong Odor and/or
- •Weather/Temperature Change Triggers (making their VMR/IR symptoms
- •worse) included on the Vasomotor/Idiopathic Rhinitis Questionnaire completed
- •at Visit 1.
- •c Negative skin tests (by prick method), response to seasonal allergens (including
- •tree, grass and weed pollens) and perennial allergens (including animal dander,
- •house dust mites, cockroach and mold) relevant to the geographical area
- •completed at Visit 1.
- •A negative response for allergen skin prick testing is defined as a wheal < 3 mm
排除标准
- •Subject will not be eligible for inclusion if any of following criteria apply:
- •1. Significant concomitant medical conditions, defined as but not limited to:
- •a Historical/current evidence of clinically significant uncontrolled disease of
- •any body system. Significant is defined as any disease that, in the opinion of
- •investigator, would put safety of subject at risk through study
- •participation or which would confound the interpretation of study results if
- •disease/condition exacerbated during study.
- •b severe physical obstruction of the nose/nasal septal perforation that could
- •affect deposition of double blind intranasal study drug
- •c nasal/throat injury or surgery in last 3 mths
- •d asthma, with exception of mild intermittent asthma.
- •e rhinitis medicamentosa
- •f bacterial/viral infection of upper respiratory tract within 2 wks of Visit 1 or
- •during screening period
- •g documented evidence of acute or significant chronic sinusitis, as determined by
- •sinus radiograph (Waters view) done at Visit 1
- •h current or history of glaucoma and/or cataracts or ocular herpes simplex
- •i physical impairment that would affect subject’s ability to participate in study
- •j clinical evidence of Candida infection of nose or oropharynx
- •k history of psychiatric disease, intellectual deficiency, poor motivation, substance
- •abuse, or other conditions that will limit validity of informed consent or that would
- •confound interpretation of study results
- •l history of or current use of cocaine
- •m history of adrenal insufficiency
- •n history of shingles
- •o Subject not eligible if has chickenpox/measles, or has been exposed
- •during last 3 wks and is non-immune. If a subject develops chickenpox/
- •measles during study, they will be withdrawn. If a non-immune subject
- •is exposed during study, their continuation will be at discretion of investigator,
- •taking into consideration likelihood of developing active disease.
- •2. Use of corticosteroids, defined as:
- •Intranasal corticosteroid within 4 wks prior to Visit 1.
- •Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological
- •corticosteroid (with exception of hydrocortisone cream/ointment, 1% or less)
- •within 8 wks prior to Visit 1.
- •3. Use of other allergy medications within timeframe indicated relative to Visit 1
- •Intranasal or ocular cromolyn within 14 days prior to Visit 1
- •Short-acting prescription and OTC antihistamines, including ocular preparations
- •and antihistamines contained in insomnia and ‘nighttime’ pain formulations
- •taken for insomnia, within 3 days prior to Visit 1
- •Long-acting antihistamines within 10 days prior to Visit 1: loratadine,
- •desloratadine, fexofenadine, cetirizine
- •Long-acting antihistamine, astemizole, within 12 wks prior to Visit 1
- •Oral or intranasal decongestants within 3 days prior to Visit 1
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