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临床试验/NCT00975403
NCT00975403已完成不适用

Pathophysiological Mechanisms of Dyspnea and Activity-Limitation in Mild COPD

Queen's University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Dyspnea intensity measured by the 10-point Borg scale during cycle exercise

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a growing cause of death, disability and health care costs in Canada. Nevertheless, COPD remains largely under-diagnosed and under-treated, particularly in its early stages. Patients with mild COPD have variable respiratory symptoms and often go unrecognized by their caregivers. Recent studies indicate that even smokers with near normal breathing test results can have extensive small airway disease/dysfunction at rest, which becomes more pronounced during the stress of exercise thus leading to unpleasant breathing difficulty. This study seeks to better understand the nature and causes of breathing discomfort and activity limitation in a group of patients with mild COPD. The investigators will compare detailed tests of small airway function and conduct an evaluation of several key physiological parameters during the stress of exercise in patients with mild COPD and in healthy, age-matched, non-smoking control subjects. The investigators will also compare detailed physiological responses to exercise under conditions of chemical loading and mechanical unloading of the respiratory system in patients with mild COPD.

The proposed study will be the first to systematically test the hypothesis that pathophysiological abnormalities in ventilatory demand, pulmonary gas exchange, small airway function, dynamic ventilatory mechanics and respiratory muscle function contribute significantly to exertional dyspnea and activity-limitation in patients with mild COPD. This study will be the first to determine if these abnormalities can be manipulated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
Triple (Participant, 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

入选标准

  • Post-bronchodilator forced expiratory volume in 1 sec (FEV1) ≥ 80%predicted and a FEV1/forced vital capacity (FVC) ratio < 0.70;
  • Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospitalizations in the preceding 6 weeks;
  • A cigarette smoking history ≥ 20 pack-yrs;
  • Body mass index between 18.5 and 30 kg/m2;
  • Able to perform all study procedures and provide informed consent.

排除标准

  • A diffusing capacity of the lung for carbon monoxide (DLCO) < 40 %predicted;
  • Presence of active cardiopulmonary disease (or comorbidities) other than COPD that could contribute to dyspnea and exercise limitation;
  • Clinical diagnosis of sleep disordered breathing;
  • History or clinical evidence of asthma;
  • 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.

结局指标

主要结局

Dyspnea intensity measured by the 10-point Borg scale during cycle exercise

时间窗: Standardized time during exercise

次要结局

  • Cycle exercise endurance time(During exercise testing at study visits)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Denis O'Donnell

Principal Investigator

Queen's University

研究点 (2)

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