SAPS:Smoking Asthmatics Pilot Study:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Asthma Control Test
研究概览
简要总结
The primary aim of the pilot (SAPS) protocol is to determine the feasibility and utility of implementing the provisional design of the full scale TOM trial (e.g., the six month treatment period, the impact of the smoking cessation intervention).
There is no active hypothesis for the Vanguard Protocol.
详细描述
The protocol is a small scale pilot of the full-scale TOM trial, and it will utilize a placebo design and incorporates 4 treatment arms. In the Vanguard Protocol all participants are to complete a 4 week run-in with Advair 100/50, followed by randomization to 1 of 4 arms of study treatment. The 4 drug treatment combinations are (2 inhalers, 2 pills):
- Advair 250/50, Placebo, Placebo, Placebo
- Advair 100/50 and montelukast, Placebo, Placebo
- Advair 100/50 and theophylline, Placebo, Placebo
- Advair 100/50 and ipratropium, Placebo, Placebo The 24 week treatment phase will be followed by a 4 week washout period on Advair 100/50. There is no crossover.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender and Age:
- •Males and females, ages 18- 50
- •Current Smoker:
- •Smoke at least 5 cigarettes per day for at least 5 years
- •Positive urine cotinine test
- •Physician diagnosed asthma
- •Symptomatic, as evidenced by
- •Use of SABA two or more times per week for relief of asthma symptoms, or
- •One or more nocturnal awakenings per week for asthma symptoms ACRC - SC MEETING - 19 MAY 2012 SAPS │ 25 Confidential, not for attribution or citation.
- •Pre-BD FEV1 greater than or equal to 40% predicted
- •Asthma diagnosis confirmed by either
- •albuterol reversibility of FEV1 by 12% or more, or
- •20% fall in FEV1 at 8mg or less of methacholine
- •If over age 45, a DLco greater than 80% predicted
- •Females of childbearing potential: not pregnant, not lactating and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
排除标准
- •Diagnosis of COPD or emphysema
- •Other major chronic illnesses in the opinion of the investigator that might interfere with the study:
- •e.g. including but not limited to uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder, hyperthyroidism, seizure disorders, renal failure, liver disease, non-skin cancer, unstable psychiatric illness.
- •Recent active substance abuse (in past 6 months)
- •Lung disease other than asthma including COPD, bronchiectasis, sarcoidosis, or other significant lung disease
- •Unstable cardiac disease (decompensated CHF, unstable angina, recent MI, atrial fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or severe uncontrolled hypertension).
- •High risk of near fatal or fatal asthma as defined by the following 1-3
- •ICU admission of asthma in the past year
- •more than 2 hospitalizations for asthma in the previous year
- •more than 3 ED visits for asthma in the previous year
- •intubation or ICU admission for asthma in the past 2 years
- •use of more than 2 canisters of inhaled short-acting beta2-agonist in past month
- •Acute asthma exacerbation in the past 4 weeks (treatment with systemic corticosteroids)
研究组 & 干预措施
Ipratropium
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and placebo montelukast.
干预措施: ipratropium (Drug)
Theophylline
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.
干预措施: Theophylline 400 mg (Drug)
Montelukast
Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.
干预措施: Montelukast 10mg (Drug)
fluticasone 250 mg/salmeterol 50mg
Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.
干预措施: Fluticasone 250 mg/salmeterol 50 mg (Drug)
结局指标
主要结局
Asthma Control Test
时间窗: Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.
The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score \<16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3.
次要结局
- The Asthma Symptom Utility Index (ASUI)(Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and a follow-up visit 1 month off study drug. Median scores, change from initial visit and end of treatment, were compared)
- Percent (%) Perdicted FEV1 Changes(Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks. Median scores over the 24 weeks of treatment were compared)
研究者
Joe Ramsdell
Medical Doctor
University of California, San Diego