EUCTR2005-004464-24-NL进行中（未招募）不适用
A Double-blind, Placebo-controlled, Randomized, Parallel-group Multicenter Study of Mometasone Furoate Nasal Spray on Sleep Disturbances and Daytime Somnolence in Subjects with Symptomatic 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
- 372
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.Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- •2.Subject must be 18 years of age and older, of either sex, and of any race.
- •3.Subject must be clinically symptomatic at the Screening Visit (Day -7 to -4: Visit 2), and must have the following nasal symptoms/signs severity scores (PRIOR-reflective) as assessed jointly by the subject and the investigator or qualified designee:
- •nasal stuffiness/congestion = 2
- •rhinorrhea/nasal discharge = 2
- •sneezing = 1
- •nasal itching = 1
- •The presence and severity of the non-nasal symptoms/signs (eye itching, eye tearing, eye redness, itching of ears and/or palate) will be recorded.
- •4.Subject must be clinically symptomatic at the Baseline Visit (Day 1: Visit 3). Scores for the seven run-in diary time points prior to and including the AM diary time point on the morning of the Baseline Visit (the three AM evaluations prior to the Baseline Visit, the AM evaluation on the day of or the Baseline Visit, and the three PM evaluations prior to the Baseline Visit) must total the following:
- •Nasal stuffiness/congestion = 14
- •Rhinorrhea/nasal discharge = 14
- •Sneezing score = 7
- •Nasal itching score = 7
- •TNSS = 42
- •The presence and severity of the non-nasal symptoms/signs (eye itching, eye tearing, eye redness, itching of ears and/or palate) will be recorded.
- •5.At the Screening Visit (Day -7 to -4: Visit 2), subject must have complaints of sleep disturbance while symptomatic with seasonal allergic rhinitis and must have a score of 30 or greater for the Sleep Disturbance Sleep Scale (items 1,3,7 and 8).
- •6.At the Baseline Visit (Day 1: Visit 3), subject must have complaints of sleep disturbance and daytime somnolence while symptomatic with seasonal allergic rhinitis and must have a score of 30 or greater for the Sleep Problems Index II (SLP9) and 30 or greater for the Daytime Somnolence Sleep Scale (items 6, 9, and 11).
- •7.Subject must have a 2-year or longer history of seasonal allergic rhinitis occurring during the same season(s) as the current study.
- •8.Subject must have skin tests (prick or intradermal) positive for outdoor allergens common in subjects with seasonal allergic rhinitis prevalent during the time of this study, such as, trees, grasses, weeds, ragweed, and molds. The skin tests should be performed at the Screening Visit (Day -7 to -4: Visit 2) if not done within 12 months prior to the Screening Visit.
- •9.Subject must be free of clinically significant disease that would interfere with study evaluations.
- •10.Female subjects of childbearing potential are required to use a medically accepted method of birth control prior to the Screening Visit (Day -7 to -4: Visit 2) and during the study, or provide documentation of surgical sterilization (eg, hysterectomy, tubal ligation). Females of childbearing potential should be counseled in the appropriate use of birth control while in this study. Females who are not sexually active at study enrollment must consent to the use a medically accepted method of birth control if/when they become sexually active during study participation.
- •11.Female subjects of childbearing potential must have a negative urine pregnancy test at the time of enrollment at the Baseline Visit (Day 1: Visit 3).
- •12.Subject must understand and be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant me
排除标准
- •The subject will be excluded from entry into the study if ANY of the criteria listed below are met:
- •1.Subject is a female who is pregnant, intends to become pregnant during the study, or is nursing.
- •2.Subject is currently taking medications prohibited during the study or has not complied with requirements for the wash-out” period(s) for medication prohibited during this study.
- •3.Subject has used any investigational product within 30 days prior to enrollment or any antibodies for asthma or allergic rhinitis in the past 90 days.
- •4.Subject has evidence of nasal polyps, deviated septum, or other intranasal anatomical obstruction(s) that would interfere with nasal airflow.
- •5.Subject has acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral nasal decongestants.
- •6.Subject has had an acute respiratory infection within 2 weeks of the Screening Visit (Day -7 to -4: Visit 2).
- •7.Subject has been diagnosed with clinically relevant sleep problems unassociated with allergies (eg, sleep apnea, narcolepsy, frequent nocturnal awakenings due to asthma).
- •8.Subject has complained (within 12 months of the Screening Visit (Day -7 to -4: Visit 2)) to their health-care provider) of difficulty sleeping or daytime sleepiness while not experiencing allergic rhinitis symptoms, and continue with these complaints.
- •9.Subject has snoring associated with an enlarged uvula or other upper airway pathology.
- •10.Subject has had episodes of snoring associated with gasping or choking.
- •11.Subject has awakened suddenly, on more than 1 occasion during the month preceding the Screening Visit (Day -7 to -4: Visit 2), with a gasping or choking feeling.
- •12.Subject requires the use of oral appliances at night for the relief of bruxism (teeth gnashing) or temporomandibular joint problems.
- •13.Subject has a diagnosis of asthma with daytime and nighttime asthma symptoms not controlled by short-acting ß-2 adrenoceptor agonists.
- •14.Subject has a dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids.
- •15.Subject is currently undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the Screening Visit (Day -7 to -4: Visit 2) and wish to remain on this schedule during the study are eligible for study inclusion; however, subjects may not receive hyposensitization treatment within 24 hours prior to any study visit.
- •16.Subject smokes, or is an ex-smoker who has smoked within the previous 6 months.
- •17.Subject is a member of the Investigational Study Staff (currently involved with this study) or a member of the staff’s family.
- •18.Subject has been previously randomized into this study.
- •19.Subject has a concomitant medical problem that may interfere with participation in the study, eg, repeated migraine episodes, uncontrolled convulsive disorders.
- •20.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.
- •21.Subject has any 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.
- •22.Subject is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
- •23.Subject is participating in
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