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临床试验/EUCTR2004-000091-14-SE
EUCTR2004-000091-14-SE进行中（未招募）不适用

A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre, Long-Term Study to Evaluate the Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 52 Weeks in Adult and Adolescent Subjects with Perennial Allergic Rhinitis

GlaxoSmithKline AB0 个研究点目标入组 736 人开始时间: 2004年6月30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
736
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 apply:
  • •1. Subject has provided an appropriately signed and dated informed consent and one has been obtained from the subject’s parent or guardian if the child is under 18 years of age.
  • •2. Subjects must be >=12 years of age at Visit 1, either gender, any ethnic group.
  • •3. Subject is treatable on an outpatient basis.
  • •4. Gender: Male or female
  • •To be eligible for entry into the study, females of child-bearing 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 the study and is the sole sexual partner for that female subject
  • •- Implants of levonorgestrel
  • •- Injectable progestogen
  • •- Oral contraceptive (either combined or progestin only)
  • •- Double barrier method – spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a spermicide and female diaphragm).
  • •- 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 and are not on one of the above acceptable methods of contraception 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).
  • •Female subjects should not be enrolled if they plan to become pregnant during the time of study participation.
  • •A urine pregnancy test will be done at the screening visit to confirm female subjects are not pregnant upon entry into the study. Urine pregnancy tests will be done for all female subjects at each monthly visit.
  • •5. Diagnosis of PAR as follows:
  • •- A positive skin test (by prick method) response to appropriate perennial allergen (animal dander, house dust mites, cockroach, mould) within last 12 months prior to Visit 1.
  • •A positive skin test is defined as a wheal >=3mm larger than the diluent control for prick testing.
  • •Two year medical history and past treatment of PAR (written or verbal confirmation) which includes perennial, i.e., year-round, symptoms. PAR symptoms would include nasal congestion, rhinorrhoea, sneezing and itching.
  • •In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed for the diagnosis of PAR.
  • •Note: Subjects who meet the above criteria and who also may have seasonal allergic rhinitis (SAR) or idiopathic rhinitis (VMR) are eligible for randomisation.
  • •6. Subject understands and is willing, able and likely to comply with study procedures and restrictions.
  • •7. Subject must be able to read, comprehend, and record information in English, or native country language.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •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 apply:
  • •1. Significant concomitant medical conditions, defined as:
  • •a) A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., active tuberculosis, psychological disorders). 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.
  • •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 study drug
  • •c) recent (in the last 6 months) nasal septal or facial cosmetic surgery
  • •d) asthma, with the exception of mild intermittent asthma [NAEPP, 2002] and the [GINA, 2003]. For Canada, see Canadian Asthma Consensus Report, [Boulet, 1999] for guidelines for very mild intermittent asthma). NOTE: Subjects will be allowed to use short-acting inhaled beta2 agonists ONLY on an as needed basis.
  • •e) rhinitis medicamentosa
  • •f) bacterial or viral infection (e.g., common cold) of the 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 in the study
  • •j) clinical evidence of a Candida infection of the nose or oropharynx
  • •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
  • •l) history of adrenal insufficiency
  • •2. Use of corticosteroids, defined as:
  • •- Intranasal corticosteroid within four weeks prior to Visit 1.
  • •- Inhaled, oral, intramuscular, intravenous, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within six months prior to Visit 1.
  • •3. Use of other allergy medications within the timeframe indicated relative to Visit 1
  • •- Intranasal 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 weeks prior to Visit 1
  • •- Oral or intranasal decongestants within 72 hours of Visit 1
  • •- Intranasal, oral or inhaled anticholinergics within 72 hours prior to Visit 1
  • •- Oral antileukotrienes within 72 hours of Visit 1
  • •- Intranasal antihistamine such as Azelastine® within 5 days prior to Visit 1
  • •4. Use of other medications that may affect allergic rhinitis
  • •- 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)
  • •- Subcutaneous omalizumab (Xolair®) within 5 months of Visit 1
  • •- Miacalcin® (intranasal calcitonin) within 72 hours prior to Visit 1
  • •5. Use of immunosuppressive m

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