NCT00791518已完成不适用
An Evaluation of Lung Function and Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) on Long-Acting Bronchodilator Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,084
- 试验地点
- 1
- 主要终点
- Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal
研究概览
简要总结
A multicenter study to evaluate lung function and symptoms in subjects with COPD who have been on regular use of only one long-acting bronchodilator.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Cigarette smoking history-Current or ex-smokers (defined as stopped smoking for at least three months prior to the study visit)
- •Established history of COPD as diagnosed by a physician
- •Regular use (prescribed for use every day) of only one long-acting bronchodilator greater than or equal to one month before the study visit
- •Ability to read, comprehend, and record information in the English language
排除标准
- •Currently active asthma (receiving asthma therapy and or having asthma symptoms)
- •Use of ipratropium/albuterol combination products greater than three times per day, use of inhaled corticosteroids, use of inhaled corticosteroid/long-acting beta-agonist combinations, theophylline preparations, or oral beta agonists within 3 months prior to the study visit
- •Previous lung surgery
- •Other respiratory disorders other than COPD
- •Current alcohol, illegal drug, or solvent abuse
- •Females with a positive urine pregnancy test at the study visit
研究组 & 干预措施
No group
No group
干预措施: No intervention (Drug)
结局指标
主要结局
Percentage of Participants Whose Post-albuterol Forced Expiratory Volume in One Second (FEV1) Was <80% Predicted Normal
时间窗: Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered)
The percentage of participants on long-acting bronchodilator (LABD) monotherapy who had a post-albuterol FEV1) \<80% predicted normal was calculated. FEV1 is the amount of air that can be expelled from the lungs in one second after a full inspiration. Predicted normal values for FEV1 were calculated using the reference values from the third National Health and Nutrition Examination Survey (NHANES III). Values are based on the participants' age, height, sex, and race; thus, normal values vary based on participants' demographics.
次要结局
- Mean Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <80% and >=80%(Day 1 of a 1-day study)
- Percentage of Participants Whose Post-albuterol FEV1 Was <50% Predicted Normal(Day 1 of a 1-day study; 15-30 min post-albuterol (self-administered))
- Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <50% and >=50%(Day 1 of 1-day study)
- Number of Participants With the Categorized Post-albuterol Forced Expiratory Volume in One Second/Forced Vital Capacity (FEV1/FVC) Ratios(Day 1 of a 1-day study)
- Mean mMRC Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <50% and >=50%(Day 1 of a 1-day study)
- Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <80% and >=80%(Day 1 of a 1-day study)
- Number of Participants With Reports of Diagnosis and/or Treatment for Specific Cardiovascular (Heart), Psychiatric (Anxiety or Depression), and/or Bone Disorders in the <80%, >=80%, <50%, and >=50% FEV1 Groups(Day 1 of a 1-day study)
- Number of Participants Who Had a COPD Exacerbation Requiring Oral Corticosteroids and/or Antibiotics With Post-albuterol FEV1 <80% and >=80%(Day 1 of 1-day study)
- Mean Modified Medical Research Council (mMRC) Dyspnea Scale Scores for Participants With Post-albuterol FEV1 <80% and >=80%(Day 1 of a 1-day study)
- Number of Participants Who Had a COPD Exacerbation Requiring Hospitalization With Post-albuterol FEV1 <50% and >=50%(Day 1 of 1-day study)
- Mean Number of Puffs From All Short-acting Bronchodilators Used in the Past Two Weeks in Participants With an FEV1 of <50% and >=50%(Day 1 of a 1-day study)
研究者
研究点 (1)
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