EUCTR2012-001389-14-DE进行中（未招募）不适用
A randomized, double-blind, placebo-controlled three-period incomplete cross over study to compare theefficacy of QAW039 alone and in combination with Montelukast in patients with allergic rhinitis using anEnvironmental Exposure Chamber - comparison of efficacy of QAW039 alone and with Montelukast in patients with Allergic rhinitis
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. Male or female aged 18-65 years inclusive, with a clinical history of intermittent allergic rhinitis
- •with seasonal onset and offset of nasal allergy symptoms during each of the last two grass
- •pollen allergy seasons.
- •2. A positive skin prick test at Visit 1 to dactylis glomerata with a wheal diameter equal to or
- •greater than 3 mm and a negative control with a wheal diameter of zero. A positive skin prick
- •test within 12 months prior to Visit 1 is also acceptable.
- •3. FEV1 measured by spirometry must be =80% of their predicted value at screening. If the
- •patient does not achieve =80% of their predicted value this may be repeated prior to the EEC
- •challenge at visit 2.
- •4. TNSS score =6 on at least one assessment during the 2h EEC challenge at Screening.
- •5. Non-smokers and ex-smokers (=10 pack years and >6 months of smoking abstinence)
- •Pack years = the number of cigarettes smoked on average per day divided by 20 over the
- •period of 1 year (e.g. 20 cigarettes per day for 1 year = 1 pack year).
- •6. Urine cotinine levels will be measured during screening and at each baseline for all
- •patients. Smokers will be defined as any subject with a positive urine cotinine test as
- •defined by the local laboratory without confirmed use of nicotine replacement therapy.
- •7. Patients must weigh at least 50 kg to participate in the study, and must have a body mass
- •index (BMI) within the range of 18 to 35 kg/m2.
- •8. Able to communicate well with the Investigator/designee, to understand and comply with
- •the requirements of the study. Understand and sign the written informed consent.
- •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 190
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of
- •enrollment, whichever is longer; or longer if required by local regulations, and for any other
- •limitation of participation in an investigational trial based on local regulations.
- •2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical
- •classes (CRTh2 antagonists)
- •3. History of malignancy of any organ system (other than localized basal cell carcinoma of
- •the skin), treated or untreated, within the past 5 years, regardless of whether there is
- •evidence of local recurrence or metastases.
- •4. Pregnant or nursing (lactating) women,
- •5. Women of child-bearing potential, defined as all women physiologically capable of becoming
- •pregnant, unless they are using effective methods of contraception during dosing of study
- •treatment. Women of child-bearing potential, defined as all women physiologically capable of
- •becoming pregnant, unless they are using effective methods of contraception during dosing of
- •study treatment.
研究者
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