Trial of Roflumilast in Asthma Management (TRIM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 7
- 主要终点
- Change in Asthma Control Test Score
研究概览
简要总结
There are currently no treatments to specifically target asthma in obese adults. This pilot study is being conducted to investigate how effective roflumilast is in treating asthma in participants that have a higher BMI. Roflumilast can induce weight loss, which may lead to improved asthma control.
The primary objective of TRIM is to perform a pilot placebo-controlled trial of roflumilast for the treatment of poorly controlled obese asthmatics.
详细描述
TRIM is a 24 week, randomized, double-masked, placebo controlled trial that will enroll 38 participants.
This study will be take place in seven centers of the American Lung Association- Airways Clinical Research Centers (ALA-ACRC). The centers include: Northwestern University Feinberg School of Medicine, Mount Sinai Icahn School of Medicine, Duke University, University of Arizona, the University of Vermont, The University of Alabama Lung Health Center, and University of Illinois Breathe Chicago Center. Johns Hopkins University will be the Data Coordinating Center (DCC) for the trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of asthma on regular prescribed controller therapy for at least 3 months
- •Previous (within five years) evidence of at least a 12% increase in forced expiratory volume at one second FEV1 after inhaling 2-4 puffs of albuterol or a positive methacholine challenge or patient reported history of improvement of asthma exacerbation after a course of systemic or inhaled corticosteroids
- •Age: ≥18 years of age
- •Obese: Body Mass Index (BMI) > 30 kg/m2
- •Poorly controlled asthma: Asthma Control Test (ACT) Score < 20, or use of rescue inhaler, on an average of> 2 uses/week for preceding month, or nocturnal asthma awakening, on an average of 1 or more times / week in preceding month, or emergency department (ED)/hospital visit or prednisone course for asthma in past six months.
- •Ability and willingness to provide informed consent
排除标准
- •Participation in an investigational study within the past 4 weeks
- •Physician diagnosis of chronic obstructive pulmonary disease
- •Any condition that puts the participant at risk from weight loss as judged by the site physician
- •Liver cirrhosis
- •Major psychiatric disorders such as generalized anxiety disorder, major depressive disorder, history of suicidal ideation/ attempt, panic disorder, post-traumatic stress disorder, schizophrenia, schizoaffective, substance abuse or other disorders that in the opinion of the study physician that would affect study participation
- •> 0 time use of illicit drugs in the past 12 months
- •> 0 time use of cannabis in the past 12 months
- •Uncontrolled depression as defined by a score of 15 or greater on the depression questions of the Patient Health Questionnaire (PHQ-9)
- •Suicidal ideation (a score of greater than 0 on Question 9 on the PHQ-9)
- •Uncontrolled anxiety as defined by a score of 10 or greater on the anxiety questions of the Generalized Anxiety Disorder 7-item (GAD-7)
- •Pregnancy/lactation
- •Females of childbearing age who do not agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
- •Greater than 20 pack year smoking history, or smoking within the last 6 months.
- •History of bariatric surgery
- •Drugs metabolized by cytochrome P450 (rifampicin, phenobarbital, carbamazepine, phenytoin, erythromycin, ketoconazole, cimetidine, fluvoxamine, enoxacin, oral contraceptives containing ethinyl estradiol with gestodene).
- •Currently on roflumilast or theophylline (patient may wash out of these medications for 4 weeks prior to visit 1)
- •Intention to move out of area within the next 6 months
研究组 & 干预措施
Roflumilast 500 mcg oral tablet
500 mcg roflumilast oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
干预措施: Roflumilast 500 Mcg Oral Tablet (Drug)
Placebo oral tablet
500 mcg placebo oral tablets will be taken every other day for the first two weeks. If participant tolerates the drug, the tablet will be taken once daily.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Change in Asthma Control Test Score
时间窗: Baseline and 24 weeks
The Asthma Control Test was designed to help participants describe their asthma and how it affects how they feel and what they are able to do. They choose a response based on their asthma within the last 4 weeks. Participants select how many times per week they experience different asthma symptoms and how often they had to use a rescue inhaler or nebulizer. There are 5 questions with 5 responses; 1 meaning their asthma is not well controlled or they had symptoms more frequently, through 5 meaning they feel their asthma is well controlled or they do not experience any symptoms. The primary outcome is an unadjusted comparison of 24 week change in Asthma Control Test scores between the treatment groups.
次要结局
- Change in Asthma Symptom Utility Index (ASUI)(baseline and 24 weeks)
- Change in Weight(Baseline and 24 weeks)
- Change in Marks Asthma Quality of Life Questionnaire(baseline and 24 weeks)
- Change in Gastrointestinal Symptom Rating Scale (GSRS)(Baseline and 24 weeks)
- Change in Generalized Anxiety Disease (GAD-7)(baseline and 24 weeks)
- Change in PHQ9(baseline and 24 weeks)
- Change in SF 36(baseline and 24 weeks)