EUCTR2004-004434-14-LV进行中（未招募）不适用
A randomised, double-blind, placebo controlled, parallel group, multicentre two week study to evaluate the efficacy and safety of once-daily, intranasal administration of GW685698X aquenous nasal spray 100mcg in adult and adolescent subjects with seasonal allergic rhinitis in Europe
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
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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