EUCTR2013-002940-94-AT进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, 3 way, incomplete block cross over study in subjects with allergic rhinitis to assess the effect of once daily single and repeat doses of intranasal Fluticasone furoate/Levocabastine fixed dose combination (FDC) relative to Levocabastine and Fluticasone furoate alone on the onset and magnitude of symptoms of rhinitis in an allergen challenge chamber
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1.Diagnosis of AR, as determined by the presence of rhinitis symptoms that last for several months per year, for more than 1 year and are not attributed to infections or nasal abnormalities.
- •2.Subjects have a TNSS score of =6 during the screening allergen challenge chamber.
- •3.Subjects have a positive skin prick test (wheal = 4mm) for seasonal pollen at or within the 12 months preceding the screening visit.
- •4.Subjects have a positive RAST (= class 2) for seasonal pollen at or within the 12 months preceding the screening visit.
- •5.There are no conditions or factors that would make the subject unlikely to be able to stay in the chamber for 5 hours.
- •6.Male/females between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- •7.Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination and laboratory tests. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- •8.Body weight =50 kg and BMI within the range 19 – 30 kg/m2 (inclusive).
- •9.A female subject is eligible to participate if she is of:
- •-Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy [for this definition, documented” refers to the outcome of the investigator's/designee’s review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records]; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory].
- •-Child-bearing potential with negative pregnancy test as determined by urine ßhCG test at screening or prior to dosing AND
- •10.Agrees to use one of the contraception methods listed in Section 4.3.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 1 week post-last dose
- •11.Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •12.Subjects should be non-smokers, which for this study is defined as having smoked
- •<10 packs per year in their lifetime, and have not smoked in the 6 months prior to the screening visit.
- •13.ALT, alkaline phosphatase and bilirubin ?1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- •14.Based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period:
- •a.QTcF < 450 msec;
- •Are the trial subjects under 18? no
- •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 72
- •F.1.3 Elderly (>=65 years) no
- •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:
- •Criteria Based Upon Medical Histories
- •1.Nasal abnormalities likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, sinusitis other nasal malformations.
- •2.History of frequent nosebleeds
- •3.Patients with rhinitis medicamentosa
- •4.Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •5.Significant renal impairment, which based on the opinion of the investigator, would preclude the subjects participation in the study.
- •6.History of regular alcohol consumption within 6 months of the study defined as:
- •7.An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
- •8.History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- •Criteria Based Upon Diagnostic Assessments
- •1.A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- •2.A positive pre-study drug/alcohol screen.
- •3.A positive test for HIV antibody.
- •Other Criteria
- •1.Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- •2.Lactating females.
- •3.The subject has participated in a clinical trial and has received an investigational
- •product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- •4.Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- •5.Chronic oral steroids discontinued less than 6 months prior to screening.
- •6.Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- •Subjects who are using some of the medications below on an as needed basis, may participate in the study if they remain free of medication for the following periods of time prior to screening and prior to dosing (study drugs):
- •Nasal antihistamines: 72 hours
- •Oral antihistamines A (cetirizine, fexofenadine, loratadine, desloratadine): 72 hours
- •Oral antihistamines B (all others): 72hours
- •Eye and Nasal Levocabastine: 7 days
- •Nasal decongestants: 24 hours
- •Oral decongestants: 24 hours
- •Nasal glucocorticosteroids: 7 days
- •Inhaled glucocorticoids: 1 week
- •Oral glucocorticosteroids: 12 weeks
- •Oral leukotriene receptor antagonists: 7 days
- •Oral 5-lipoxygenase inhibitors: 7 days
- •Oral methylxanthines: 7 days
- •Subjects with recent upper respiratory tract infections (URTIs) will be allowed in the study only if their nasal symptoms associated with the URTI have been completely resolved for more than 3 weeks prior to screening.
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