EUCTR2008-001567-10-DE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, 3-period crossover study to assess the efficacy and safety of single dose intranasal GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic rhinitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
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
- Male
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. The subject is healthy with the exception of seasonal allergic rhinitis. The subject may also have mild asthma. Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a 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.
- •2. Aged between 18 - 65 years.
- •4. Body weight = 50 kg and BMI within the range 19 - 32kg/m2.
- •5. They have a history of seasonal allergic rhinitis
- •6. They exhibit a moderate response to 4000 grass pollen grains/m3 within 2h in the Environmental Challenge Chamber, which is defined as a nasal symptom score of =6 at least once (Nasal symptom score is the sum of nasal blockage, rhinorrhoea, itch and sneeze, each of which have been scored on a scale from 0 to 3).
- •7. They have a positive skin prick test (wheal = 3mm) for Dactylis glomerata (at or within the 12 months preceding the screening visit).
- •8. They have a baseline FEV1 = 80% predicted.
- •9. A non-smoker for at least the past 12 months with a pack history of <10 pack years.
- •10. There are no conditions or factors that would make the subject unlikely to be able to stay in the chamber for 6 hours.
- •11. They are capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •12. They are available to complete all study measurements.
- •13. Able to use the intranasal Nasal Spray satisfactorily.
- •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
- •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:
- •1. On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection which in the responsible Physician’s opinion renders the subject unsuitable for participation in the study.
- •2. Any respiratory disease other than mild stable intermittent asthma [Global Initiative for Asthma (GINA) Guidelines, 2003] that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
- •3. The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication. The subject is concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or Nasal Spray.
- •4. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- •5. The subject has donated a unit of blood (450mL) within the previous 3 months or intends to donate within 3 months of completing the study.
- •6. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) 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 sponsor the medication will not interfere with the study procedures or compromise subject safety.
- •7. 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 physician responsible, contraindicates their participation.
- •8. History of alcohol/drug abuse or dependence within 12 months of the study
- •9. Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- •10. The subject has a positive pre-study urine drug/breath alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
- •11. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- •12. The subject has tested positive for HIV antibodies.
- •13. The subject is at risk of non-compliance with the study procedures/restrictions.
- •14. Subjects showing clinical symptoms of perennial allergic rhinitis.
- •15. History of a respiratory tract infection and/or exacerbation of asthma within 3 weeks before the screening.
- •16. Administration of oral, injectable or dermal corticosteroids within 8 weeks or intranasal and/or inhaled corticosteroids 3 weeks prior to the screening visit.
- •17. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic
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