EUCTR2007-004683-45-IT进行中（未招募）1 期
An exploratory study of mometasone furoate nasal spray in patients with moderate-severe persistent allergic rhinitis and intermittent asthma: effects on the quality of life evaluated with the Rhinasthma questionnaire - ND
SCHERING-PLOUGH0 个研究点目标入组 56 人开始时间: 2008年2月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
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
入选标准
- •Subjects must be outpatients ( 18 and ≤ 75 years of age) of either sex. Subjects must demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent. Subjects must have moderate/severe persistent allergic rhinitis with a history of intermittent asthma from at least 2 years and actual asthma (symptoms in the last 4 weeks). The diagnosis of moderate-severe persistent rhinitis will be made on a clinical basis, according to the Allergic Rhinitis and its Impact on Asthma (ARIA) criteria. The diagnosis of intermittent asthma will be based on the criteria of the Global Initiative for Asthma (GINA) guideline). In order for a subject to qualify at the randomization visit (visit 2) the daily average of the T5SS [(Morning-time T5SS + Evening-time T5SS)/2] must be ≥ 6 in at least 4 days during the 1 week run-in period. A positive (weal diameter >3 mm) skin prick test (SPT) and/or CAP-RAST (class II or higher) performed in the 6 months prior to the start of the trial are required for at least house dust mite and 1 pollen allergen (grass or Parietaria, IgE level >3.5 U/mL). The SPTs should have been performed with a standard panel of allergens common in our region, including the following: dust mites, grasses, parietaria, birch, alder, olive, cypress, cat, dog, Alternaria and Aspergillus. Subjects must confirm that all prior medication washout times have been observed (see Section 6.2); Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who are postmenopausal for >1 year (i.e. women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study. Acceptable methods of contraception include condoms (male and female) with a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (e.g., hysterectomy or tubal ligation). If subject is a female volunteer of childbearing potential, she must have a negative urine pregnancy test at Screening/Visit 1. Subjects must be free of any clinically relevant disease (other than persistent allergic rhinitis and intermittent asthma) that would interfere with study evaluations. Subjects must be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, use of IMP and rescue medications in a daily diary.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Subject is a female who is pregnant, or intends to become pregnant during the study or within 12 weeks after study completion; 2)Subject is nursing, or intends to be nursing during the study or within 12 months after study completion; 3)Subject is currently taking medications prohibited during the study or has not complied with the requirements for the designated washout periods for any of the prohibited medications outlined in Section 6.2; 4)Subject has anatomical abnormalities of the nose (turbinate hyperthrophy, septal deviation, polyps) that would interfere with nasal airflow; 5)Subject has acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants; 6)Subject has rhinitis medicamentosa; 7)Subject has evidence of persistent asthma, or asthma with daytime and night-time symptoms not controlled by short-acting beta2-adrenoceptor agonists; 8)Subjects with asthma who require chronic use of inhaled or systemic corticosteroids; 9)Subjects who have had an upper respiratory tract or sinus infection that requires antibiotic therapy and have not had at least a 14-day wash-out period prior to the run-in period, or who have had a viral upper respiratory infection within 7 days prior to screening; 10)Subject has a dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids; 11)Subject is currently undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the screening visit (Visit 1) and wish to remain on this schedule during the study are eligible for study inclusion; however, subject may not receive hyposensitization treatment within 24 hours prior to any study visit; 12) Subject has been diagnosed of cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas); 13) Subject has a concomitant medical problem that may interfere with participation in the study, e.g., repeated migraine episodes, uncontrolled convulsive disorders; 14) Subject has any of the following clinical conditions: active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex; 15) Subject smokes, or is an ex-smoker who has smoked within the previous 6 months; 16) Subject is a member of the staff, is affiliated with, or is a family member of the staff personnel directly involved with this study; 17) Subject has been previously randomized into this study; 18) Subject has any other clinically significant deviation from normal in the physical examination or medical history that, in the investigator?s judgment, may interfere with the study evaluation or affect subject safety; 19) Subject is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study; 20) Subjects who have used any drug or device in an investigational protocol in the 30 days prior to visit 1; 21) Subject is participating in any other clinical studies; 22) Subject is allergic to or has sensitivity to the study drug or its excipients; 23) Subject has compromised ability to provide informed consent; 24) Subject has a history of non-compliance with medication or treatment protocols.
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