A randomized, double-blind, placebo controlled, incomplete block, 3 way cross over study in subjects with allergic rhinitis to assess the effect of intranasal repeat doses of SB-705498 when administered alone or in conjunction with intranasal fluticasonepropionate on the symptoms of rhinitis in the Vienna allergen challenge chamber.

GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 72 人开始时间: 2011年3月31日最近更新: 2012年4月3日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 72

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

•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 =4 following the screening allergen challenge
•chamber. (Total nasal symptom score is the sum of nasal congestion, rhinorrhoea,
•nasal itch and sneeze, each of which are scored on a scale from 0 to 3).
•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. Healthy as determined by a responsible and experienced physician, based on a
•medical evaluation including medical history, physical examination and laboratory
•tests, with the exception of AR and mild asthma not requiring treatment. A subject
•with a clinically significant clinical abnormality or laboratory parameters outside the
•reference range for the population being studied may be included only if the
•Investigator and the GSK Medical Monitor agree that the finding is unlikely to
•introduce additional risk factors and will not interfere with the study procedures.
•6. Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
•7. 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; or postmenopausal defined as 12
•months of spontaneous amenorrhea [in questionable cases a blood sample with
•simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol <40 pg/ml (<147 pmol/L) is confirmatory]. Females on hormone replacement
•therapy (HRT) and whose menopausal status is in doubt will be required to use
•one of the contraception methods in Section 8.1 if they wish to continue their
•HRT during the study. Otherwise, they must discontinue HRT to allow
•confirmation of post-menopausal status prior to study enrollment. For most
•forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy
•and the blood draw; this interval depends on the type and dosage of HRT.
•Following confirmation of their post-menopausal status, they can resume use of
•HRT during the study without use of a contraceptive method.
•Child-bearing potential and agrees to use one of the contraception methods
•listed in Section 8.1 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 84 days after the last dose of study medication.
•8. Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 84 days after the last dose of study medication.
•9. There are no conditions or factors that would make the subject unlikely to be able to stay in the chamber for 4 hours.
•10. Body weight = 45kg (female) and =50kg (male) and BMI within the range 19 –
•29.9kg/m2 (inclusive).
•11. Subjects have a screening pre-challenge FEV1 = 80% and a baseline FEV1/FVC =
•70% of the predicted value.

排除标准

•1. Nasal abnormalities likely to affect the outcome of the study, i.e. nasal septal
•perforation, nasal polyps, other nasal malformations.
•2. History of frequent nosebleeds.
•3. Respiratory disease, other than mild asthma not requiring treatment and associated with normal lung function.
•4. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
•result within 3 months of screening
•5. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
•(with the exception of Gilbert's syndrome or asymptomatic gallstones).
•6. Positive pre-study drug/alcohol/smoking screen. A minimum list of drugs that will
•be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids,
•benzodiazepines and methadone.
•7. A positive test for HIV antibody.
•8. History of regular alcohol consumption within 6 months of the study defined as:
•an average weekly intake of >21 units for males or >14 units for females. One
•unit is equivalent to 8g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml)
•of wine or 1 (25 ml) measure of spirits.
•9. 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).
•10. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
•11. 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:
•Nasal antihistamines: 72 hours
•Oral antihistamines A (cetirizine, fexofenadine, loratadine, desloratadine): 72
•Oral antihistamines B (all others): 72hours
•Nasal decongestants: 24 hours
•Oral decongestants: 24 hours
•Nasal glucocorticosteroids: 24 hours
•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.
•12. 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.
•13. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
•14. Pregnant females as determined by positive serum or urine hCG test at screening or
•prior to dosing.
•15. Lactating females.
•16. Unwillingness or inability to follow the procedures outli

研究者

发起方

GlaxoSmithKline Research and Development Ltd

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