NCT00070707已完成4 期
Efficacy and Safety of Nasonex vs. Placebo in Subjects With SAR and Concomitant Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 188
- 主要终点
- Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS)
研究概览
简要总结
This study will compare mometasone nasal spray to placebo in treating the nasal and asthma symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have at least a two-year history of seasonal allergic rhinitis and an increase in asthma symptoms associated with the allergy season under study
- •Demonstrate an increase in absolute FEV 1 less than 12%, with an absolute volume increase of at least 200 ml, after reversibility testing within the past 12 months
- •Is skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with the wheal diameter at least 7 mm larger than diluent control) at screening, or within 12 months prior to the screening visit, to a seasonal allergen (which may include seasonal molds) prevalent during the study period.
- •Female participants of childbearing potential use a medically accepted method of birth control and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). Females who are not sexually active at time of study agree and consent to use a medically acceptable method of birth control should they become sexually active while participating in the study.
排除标准
- •Female participants who are pregnant, intend to become pregnant during the duration of the study, or are nursing.
- •Have asthma symptoms and require chronic use of inhaled or systemic corticosteroids.
- •Have current or historical frequent (2 or more episodes per year for the past 2 years), clinically significant sinusitis or chronic purulent postnasal drip.
- •Have recent nasal septum ulcers, nasal surgery or nasal trauma, which should not be included until healing occurs.
- •Have rhinitis medicamentosa or chronic obstructive pulmonary disease (COPD).
- •Have an upper or lower respiratory tract or sinus infection that requires antibiotic therapy, or have a viral upper or lower respiratory infection.
- •Have nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interferes with nasal air flow.
- •Are dependent on nasal topical antihistamines, or nasal steroids.
- •On immunotherapy (desensitization therapy) and will receive an increase in dose during the study; participants who will receive desensitization treatment within 24 hours prior to a study visit.
- •Is a participant who smokes, or is an ex-smoker who has smoked within the previous six months.
- •Is an investigator, study staff member, or family member involved with this study.
- •Has active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, or systemic viral infections, or herpes simplex.
- •Is a participant whose ability to provide informed consent is compromised.
- •Has a history of non-compliance with medications or treatment protocols.
- •Is morbidly obese (BMI >35).
- •Is a night-shift worker or does not have a standard asleep at night/awake during the day cycle.
- •Has any history of life-threatening asthma attacks or is treated in the emergency room or admitted to the hospital for asthma control within the previous 3 months or more than once in the previous 6 months
研究组 & 干预措施
Mometasone
Experimental
Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks
干预措施: Mometasone (Drug)
Mometasone
Experimental
Mometasone nasal spray 200 mcg, administered once daily (QD) for 4 weeks
干预措施: Albuterol/Salbutamol (Drug)
Placebo
Placebo Comparator
Matching placebo nasal spray, administered QD for 4 weeks
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Matching placebo nasal spray, administered QD for 4 weeks
干预措施: Albuterol/Salbutamol (Drug)
结局指标
主要结局
Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS)
时间窗: Baseline up to Week 4
Each morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her asthma symptoms. The TASS was the sum of severity scores for 4 asthma symptoms: cough, wheeze, difficulty of breathing, and chest tightness. The severity of each asthma symptom was rated on a 4-point scale (0=no symptom; 3=severe); minimum TASS=0; maximum TASS=12. A decrease in TASS indicated an improvement in asthma symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19).
次要结局
- Change From Baseline in AM and PM Wheeze Symptom Score(Baseline up to Week 4)
- Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS)(Baseline up to Week 4)
- Change From Baseline in AM and PM Rhinorrhea Symptom Score(Baseline up to Week 4)
- Change From Baseline in AM and PM Cough Symptom Score(Baseline up to Week 4)
- Change From Baseline in Pulmonary Auscultation/Wheezing Assessment(Baseline, Day 15 and Day 29)
- Change From Baseline in AM and PM Nasal Sneezing Symptom Score(Baseline up to Week 4)
- Change From Baseline in AM and PM Nasal Congestion Symptom Score(Baseline up to Week 4)
- Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%)(Baseline, Day 15 and Day 29)
- Change From Baseline in AM and PM Chest Tightness Symptom Score(Baseline up to Week 4)
- Change From Baseline in Forced Vital Capacity (FVC)(Baseline, Day 15 and Day 29)
- Change From Baseline in AM and PM Difficulty Breathing Symptom Score(Baseline up to Week 4)
- Change From Baseline in Forced Expiratory Volume in One Second (FEV1)(Baseline, Day 15 and Day 29)
- Change From Baseline in AM and PM Nasal Itching Symptom Score(Baseline up to Week 4)
- Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR)(Baseline up to Week 4)
- Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used(Baseline up to Week 4)
- Change From Baseline in Weekly Average Interference With Daily Activities(Baseline up to Week 4)
- Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma(Baseline up to Week 4)
- Change From Baseline in Weekly Average Interference With Sleep(Baseline up to Week 4)
- Therapeutic Response to Asthma Symptoms(Day 15 and Day 29)
- Therapeutic Response to SAR Nasal Symptoms(Day 15 and Day 29)
研究者
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