Increased Lung Volume as Controller Therapy for Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in impedance of lung in response to methacholine measured by forced oscillation
研究概览
简要总结
This is an early phase clinical trial to test the efficacy of elevating lung volume with positive expiratory pressure (CPAP) as a controller therapy for asthma in patients with a BMI ≥ 30 kg/m2.
There will be two phases to this trial.
Phase I:
In the first phase we will determine the optimal duration of CPAP that is effective as a controller therapy in asthma. Up to 9 participants will complete this this phase.
Phase II:
The 2nd phase will be a randomized double-blinded controlled trial of Sham CPAP versus CPAP 10 (using the duration of CPAP determined in phase I) as a controller therapy for asthma, and also to determine the effect o airway reactivity in healthy people with a BMI 30 kg/m2 and above. Twenty people with asthma and twenty controls will complete this phase.
详细描述
The effect of 10 versus 0 cmH2O CPAP on airways responsiveness to inhaled methacholine will be studied using an adaptive "3+3" phase I/II study design.
Dose Titration Phase (phase I):
The efficacy of 8 hours of CPAP on airway responsiveness will be tested in three subjects.
Efficacy will be defined as a 25% improvement in the impedance response to methacholine in all three subjects. If this occurs in all subjects, shorter durations of CPAP will be studied (4 hours then one hour).
Conversely, if "dose escalation" is required, 3 nights, then 7 nights of CPAP will be studied.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for people with asthma:
- •Physician diagnosis of asthma
- •PC20 to methacholine < 16 mg/ml
- •IgE < 100 IU/ml
- •Ages 18-65 years
- •BMI >=30 kg/m2
- •Inclusion Criteria for controls:
- •No physician diagnosis of asthma
- •PC20 to methacholine > 16 mg/ml
- •IgE < 100 IU/ml
- •Ages 18-65 years
- •BMI >=30 kg/m2
排除标准
- •FEV1 < 60 % predicted
- •Other significant disease that in the opinion of the investigator would interfere with study.
- •Inability to perform required testing.
- •Smoking within last 6 months.
- •≥ 20 pack year smoking history
- •Inability to provide informed consent
- •Known obstructive sleep apnea/ high likelihood of obstructive sleep apnea
- •Asthma exacerbation in the prior 6 weeks
- •Stoke or heart attack in the prior 3 months
- •Known aortic aneurysm
- •Renal failure
- •A known severe heart, vascular, liver, renal, or hematological disease
- •Active allergic rhinitis
- •Recent eye surgery (within the last month)
研究组 & 干预措施
Sham CPAP
Participants will be randomized to Sham CPAP
干预措施: CPAP (Device)
CPAP 10
Participants will be randomized to CPAP 10
干预措施: CPAP (Device)
结局指标
主要结局
Change in impedance of lung in response to methacholine measured by forced oscillation
时间窗: Through study completion, an average of one week
Average change in impedance in response to methacholine in participants assigned to Sham CPAP versus CPAP 10
次要结局
- Change in spirometric lung function (FEV1 and FVC)(Through study completion, an average of one week)
- Change in asthma control(Through study completion, an average of one week)
研究者
Anne Dixon
Professor of Medicine
University of Vermont