Effect of Inhaled Nebulized Fentanyl on Exertional Dyspnea and Exercise Tolerance in Patients With Moderate-to-severe COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise
研究概览
简要总结
Breathing discomfort (dyspnea) and activity limitation are dominant symptoms of chronic obstructive pulmonary disease (COPD) and contribute to poor health-related quality of life in this population. Several small, uncontrolled studies and published case reports have provided evidence that inhaled fentanyl, a powerful pain relieving (opioid) medication, may be used to effectively reduce breathing discomfort in patients with advanced disease. However, the mechanisms of this improvement remain unclear. Therefore, the investigators plan to conduct the first randomized, double-blind, placebo-controlled, crossover study designed to explore the possible mechanisms of action of inhaled fentanyl on activity-related dyspnea and exercise performance in patients with advanced COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-bronchodilator forced expiratory volume in 1 sec (FEV1) 30-79% predicted, FEV1/forced vital capacity (FVC) ratio <70%;
- •Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding 6 weeks;
- •A cigarette smoking history ≥20 pack-years;
- •Significant chronic activity-related dyspnea as defined by a Baseline Dyspnea Index focal score ≤ 6;
- •Body mass index (BMI) between 18.5 and 30.0 kg/m2;
- •Able to perform all study procedures and provide/sign informed consent.
排除标准
- •A diffusing capacity of the lung for carbon monoxide (DLCO) <40 %predicted;
- •Presence of active cardiopulmonary disease other than COPD that could contribute to dyspnea and exercise limitation;
- •Clinical diagnosis of sleep disordered breathing;
- •A history/clinical evidence of asthma, atopy and/or nasal polyps;
- •History of allergy or adverse reaction to fentanyl;
- •Presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s);
- •Use of daytime oxygen or exercise-induced arterial oxygen desaturation to <80% on room air;
- •Use of antidepressant drugs (i.e., monoamine oxidase inhibitors, serotonin reuptake inhibitors) in previous 2 weeks;
- •Use of opioid or pain relieving drugs (e.g., morphine, fentanyl, oxycodone, hydromorphone, methadone, levorphanol, codeine, hydrocodone, meperidine) in previous 4 weeks.
研究组 & 干预措施
placebo
nebulized 0.9% saline placebo
干预措施: normal saline (placebo) (Drug)
fentanyl
nebulized fentanyl citrate (50 mcg)
干预措施: fentanyl (Drug)
结局指标
主要结局
Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise
时间窗: 10-minutes post-treatment
The 10-point Borg scale ranges from 0 "nothing at all" to 10 "maximal/extremely strong" and was used to rate the intensity of dyspnea during exercise; therefore, a decrease in this rating signifies an improvement. Dyspnea intensity was assessed at the highest equivalent standardized time achieved in both post-treatment constant work rate cycle exercise tests.
次要结局
- Cycle Exercise Endurance Time(10-minutes post-treatment)
研究者
Dr. Denis O'Donnell
Principal Investigator
Queen's University