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临床试验/EUCTR2004-004434-14-SE
EUCTR2004-004434-14-SE进行中（未招募）不适用

A randomized, double-blind, placebo-controlled, parallel group, multicenter twoweek study to evaluate the efficacy and safety of once-daily, intranasaladministration of GW685698X aqueous nasal spray 100 mcg in adult andadolescent subjects with seasonal allergic rhinitis in Europe

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 288 人开始时间: 2005年2月7日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
288
研究概览入排标准研究者记录与标识符相似试验

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
  • •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 under 18 years of age.
  • •2. Outpatient
  • •Subject is treatable on an outpatient basis.
  • •3. Age =12 years at Visit 2
  • •4. Male or eligible female
  • •To be eligible for entry into the study, females of childbearing potential must commit
  • •to the 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 the study and
  • •is the 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 two weeks 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 the
  • •screening visit and the final visit. A urine pregnancy test will be performed at the
  • •randomization visit.
  • •5. Diagnosis of seasonal allergic rhinitis (SAR)
  • •SAR is defined as follows:
  • •Documented clinical history of SAR with seasonal onset and offset of nasal
  • •allergy symptoms during each of the last 2 grass pollen seasons and
  • •A positive skin test (by prick method) to a grass pollen that will be abundant in
  • •the subjects environment during the course of the study within 12 months prior
  • •to Visit 1 or at Visit 1.
  • •A positive skin test is defined as a wheal =3 mm larger than the diluent control for
  • •prick testing.
  • •Historical in vitro tests for specific IgE (such as RAST, PRIST) will be allowed as a
  • •diagnosis of SAR if conducted less than 12 months prior to Visit 1.
  • •Subjects who meet the above criteria and who may also have perennial allergic
  • •rhinitis or vasomotor rhinitis are still eligible for randomization.
  • •6. Adequate exposure to the relevant grass pollen
  • •Subject resides within a geographical region where exposure to the pollen that
  • •triggers their SAR symptoms and is predicted to be significant during the entire
  • •study period.
  • •Subject does not plan to travel outside the geographical region where exposure
  • •to the relevant grass pollen is expected to be significant for more than 48 hours
  • •of the study period.
  • •7. Ability to comply with study procedures
  • 另有 11 项未显示

排除标准

  • •1. Significant concomitant medical conditions, defined as but not limited to:
  • •a. A historical or current evidence of clinically significant uncontrolled disease of
  • •any body system (e.g., tuberculosis, psychological disorders, eczema).
  • •b. a severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or
  • •nasal septal perforation that could affect the deposition of double blind intranasal
  • •c. nasal (e.g., nasal septum), ocular, or throat injury or surgery in the last 3 months
  • •d. asthma, with the exception of mild intermittent asthma (NAEPP, 2002 and GINA, 2003).
  • •e. rhinitis medicamentosa
  • •f. bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory
  • •tract within two weeks of Visit 1 or during the screening period
  • •g. documented evidence of acute or significant chronic sinusitis, as determined by
  • •the individual investigator
  • •h. current or history of glaucoma and/or cataracts or ocular herpes simplex
  • •i. physical impairment that would affect subject's ability to participate safely and
  • •fully in the study
  • •j. clinical evidence of a Candida infection of the nose
  • •k. history of psychiatric disease, intellectual deficiency, poor motivation, substance
  • •abuse (including drug and alcohol) or other conditions that will limit the validity
  • •of informed consent or that would confound the interpretation of the study results
  • •2. Use of corticosteroids, defined as:
  • •Intranasal corticosteroid within four weeks prior to Visit 1.
  • •Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological
  • •corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less)
  • •within eight weeks prior to Visit 1.
  • •3. Use of other allergy medications within the 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 night time pain formulations,
  • •within 3 days prior to Visit 1
  • •Long-acting antihistamines within 10 days prior to Visit 1 (e.g., loratadine,
  • •desloratadine, fexofenadine, cetirizine)
  • •Intranasal antihistamines (e.g., Astelin/ ) within 2 weeks prior to Visit 1
  • •Oral or intranasal decongestants within 72 hours prior to Visit 1
  • •Long-acting beta-agonists within 72 hours prior to Visit 1
  • •Intranasal, oral, or inhaled anticholinergics within 72 hours prior to Visit 1
  • •Oral antileukotrienes within 72 hours of Visit 1
  • •Subcutaneous omalizumab (Xolair) within 5 months of Visit 1
  • •Subjects are not permitted to use any ocular antihistamines, artificial tears,
  • •eyewashes/nasal irrigation solutions, allergy homeopathic or herbal
  • •preparations, lubricants, sympathomimetic or vasoconstrictor preparations
  • •during the screening and treatment periods. No exclusion period prior to
  • •screening (Visit 1) is required for these treatments.
  • •4. Use of other medications that may affect allergic rhinitis or its symptoms
  • •Chronic use of concomitant medications, such as tricyclic antidepressants, that
  • •would affect assessment of the effectiveness of the study drug
  • •Chronic use of long-acting beta-agonists (e.g., salmeterol)
  • •Use of other intranasally administered medications (e.g., calcitonin-salmon)
  • •Use of throat treatments (e.g., such as cough lozenges, throat sprays)
  • •5. Use of immunosuppressive medications 8 weeks prior to screening and during the
  • •6. Immunotherapy
  • 另有 1 项未显示

研究者

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