Study of Asthma and Nasal Steroids for the American Lung Association-Airways Clinical Research Centers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 388
- 试验地点
- 19
- 主要终点
- Asthma Control Test (ACT)
研究概览
简要总结
The trial will study the effectiveness of nasal steroids for the treatment of chronic rhinitis and/or sinusitis on asthma control.
详细描述
Previous trials completed by the American Lung Association-Airways Clinical Research Centers (ALA-ACRC) network have identified rhinitis and/or sinusitis as a significant co-morbidity in people with asthma that affects asthma symptoms and control. The objective of this clinical trial is to determine if treatment of chronic rhinitis and/or sinusitis with nasal steroids improves control of asthma in children and adults. Although chronic rhinitis and/or sinusitis have been associated with poor asthma control and increased health care utilization, the effect of treating these diseases on asthma control is not known. This will be a six-month randomized, double-blinded, placebo-controlled trial enrolling 380 participants, 190 children and 190 adults, with poorly controlled asthma and chronic rhinitis/sinusitis. Participants will be randomized to receive nasal steroid or a matching placebo in addition to their regular asthma treatments. The primary objective of the trial will be to evaluate whether the addition of treatment with nasal steroids improves asthma control. We will perform allergy skin testing on all participants and keep a record of pollen counts at all centers, to determine if allergy is an important factor in the response to nasal steroid in participants.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosed asthma
- •At least 12% increase in forced expiratory volume at one second (FEV1) after 2-4 puffs of albuterol or positive methacholine challenge (20% fall in FEV1 at less than 16 mg/ml methacholine); either of these can be available from the last 2 years before enrollment
- •Poorly controlled asthma as documented by a score of 19 or less on the Asthma Control Test (ACT) for participants 12 and older, and a Childhood Asthma Control Test (C-ACT) for 6-11 years(both V1 and V2).
- •Chronic symptoms of rhinitis and sinusitis as measured by a mean score of 1 on the Sino-nasal questionnaire
- •Males and females, age 6 and older
排除标准
- •Co-morbidity that predisposes to complicated rhino-sinusitis (e.g., cystic fibrosis, insulin dependent diabetes mellitus, immunodeficiency disorder)
- •Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney or nervous system.
- •History of sinus surgery in last 6 months
- •Systemic/nasal steroids within last 4 weeks
- •Anti-leukotriene medication
- •History of upper airway symptoms for less than 8 weeks at the time of enrollment
- •Fever > 38.3 degrees Celsius or patient history of fever in last 10 days
- •Greater than 10 pack year smoking history or active smoking within the last 6 months
- •FEV1 < 50% predicted
- •Females of childbearing potential that are pregnant or lactating, or unwilling to practice an adequate birth control method
- •Allergy or intolerance to nasal mometasone
- •Cataracts, history of glaucoma, or other conditions resulting in increased intraocular pressure
- •Any investigational drug in the last 6 weeks
- •Inability to comply with study procedures, including:
- •Inability or unwillingness to provide informed consent (or assent in the case of a minor)
- •Inability to take study medication
- •Inability to perform baseline measurements
- •Completion of less than 10 of the 14 days of screening period diary entry
- •Inability to be contacted by phone
- •Intention to move out of the area within 6 months
研究组 & 干预措施
Nasal Steroid
Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
干预措施: Mometasone Furoate monohydrate (Drug)
Placebo
Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
干预措施: Placebo (Other)
结局指标
主要结局
Asthma Control Test (ACT)
时间窗: 24 weeks
Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control
次要结局
- Childhood Asthma Control Test(24 weeks)