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临床试验/NCT00202176
NCT00202176已完成4 期

The Effects of Bronchodilators on Exertional Dyspnea and Exercise Performance in Mild Chronic Obstructive Pulmonary Disease (COPD) Patients and Healthy Elderly Subjects.

Queen's University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
32
试验地点
1
主要终点
endurance time

研究概览

简要总结

In people with mild COPD, the ability to exhale air from the lungs is partly limited because of narrowing and collapse of the airways. This results in the trapping of air within the lungs and over-distention of the lungs and chest (lung hyperinflation).

Breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing as this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can be taken orally, through injection or through inhalation and begin to act almost immediately but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients with mild COPD.

详细描述

In people with mild COPD, the ability to exhale air from the lungs is partly limited because of narrowing and collapse of the airways. This results in the trapping of air within the lungs and over-distention of the lungs and chest - this is known as lung hyperinflation. We believe that breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing; this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can be taken orally, through injection or through inhalation and begin to act almost immediately but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients with mild COPD.

Each subject will attend 4 visits to the laboratory. Visit 1 (screening visit) will involve a record of medical history, medications used, anthropometrics measurements, questionnaires, breathing tests, an incremental cycle exercise test and a constant-workload cycle exercise test. Visit 2 will involve breathing tests and a constant-workload cycle exercise test. Visits 3 and 4 will involve breathing tests and a constant-workload cycle exercise test after subjects have been randomized to either placebo or Atrovent. These visits will be done on separate days and subjects will receive the two above treatments in random order.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of mild COPD OR healthy control subjects
  • 40-80 years old
  • able to perform all study procedures
  • Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years (for healthy control subjects)

排除标准

  • allergy to atrovent
  • history of asthma, atopy or nasal polyps
  • Oxygen desaturation < 80 % during exercise
  • recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation

研究组 & 干预措施

1

Experimental

Ipratropium Bromide

干预措施: Ipratropium Bromide (Drug)

2

Placebo Comparator

Saline Solution (0.9% NaCl)

干预措施: Ipratropium Bromide (Drug)

结局指标

主要结局

endurance time

时间窗: 2 hours post-study drug inhalation

dyspnea

时间窗: 2 hours post-study drug inhalation

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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