NCT00442468已完成不适用
An Evaluation of the Prevalence of Airway Obstruction Consistent With Chronic Obstructive Pulmonary Disease (COPD) in Subjects With a History of Cigarette Smoking and Symptoms of Chronic Bronchitis in a Primary Care Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,283
- 试验地点
- 1
- 主要终点
- Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%
研究概览
简要总结
The study does not involve testing of a drug (no treatment intervention). The study will will use spirometry (breathing tests) in subjects of 40 years of age and older with a history of cigarette smoking with chronic bronchitis to check their disease status and whether or not they have COPD. Also, study subjects will be asked to complete a questionnaire (to answer a list of questions on paper).
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
- •Male or female - ≥40 years of age - Current or previous cigarette smoker with a history of cigarette smoking of ≥10 pack/years - Self reported symptoms of chronic bronchitis where chronic bronchitis is defined as the presence of productive cough for at least 3 months in each of the successive 2 years - Completion of written informed consent prior to study participation - Subject must be able to read, comprehend, and record information in English.
排除标准
- •Regular use (i.e., prescribed for use on a daily basis) of the following respiratory medications for the six months prior to the study visit: ipratropium, ipratropium/albuterol combinations, tiotropium, salmeterol, formoterol, inhaled corticosteroids, inhaled corticosteroid/long-acting beta-agonist combinations, theophyllines, oral beta-agonists. - Previous lung surgery, including, lung transplant, lung resection, lung volume reduction surgery, etc. - Current diagnosis of a significant lung condition other than chronic bronchitis, including, asthma, lung cancer, cystic fibrosis, pulmonary fibrosis, bronchiectasis, active tuberculosis, sarcoidosis, or alpha-1-antitrypsin deficiency. - Any medical or physical condition that would interfere with the adequate performance of spirometry. - Evaluation and/or treatment by a pulmonary specialist (e.g., pulmonologist or allergist) within 3 years of the study visit. - A spirometrically confirmed diagnosis of COPD. - Have, in the opinion of the investigator, evidence of current alcohol, illegal drug or solvent abuse. - Limited ability to provide a valid informed consent due to serious uncontrolled psychiatric disease, intellectual or cognitive deficiency, poor motivation or other relevant condition which in the opinion of the site principal investigator will interfere with the subject's participation in the study. - Pregnant females. - Participating investigator, sub-investigator, study coordinator, employee of the participating investigator or family members of the aforementioned site staffs.
结局指标
主要结局
Number of Participants With a Post-bronchodilator FEV1/FVC <=70% Versus Participants With a Postbronchodilator FEV1/FVC >70%
时间窗: Day 1 of a 1-day Study; before and 15-30 min after albuterol (self-administered under supervision of trained site staff)
Ratio of Forced Expiratory Volume in 1 second (volume of air expelled from the lungs in 1 second) by the Forced Vital Capacity (FVC, the volume of air that can forcibly be blown out after full inspiration) is a spirometric measure (lung function test) used to demonstrate airway obstruction. FEV1/FVC \<=0.7 is used to demonstrate airway obstruction characteristic of chronic obstructive pulmonary disease (COPD).
次要结局
- Number of Participants With the Indicated Scores on the MRC (Medical Research Council) Dyspnea Scale(Day 1 of a 1-day study)
- Number of Participants With an Affirmative Response to Specific Categories on the Modified American Thoracic Society (ATS) Respiratory Questionnaire(Day 1 of 1-day study)
- Number of Participants With the Indicated Responses to the Question of How They'd Rate Their General Health, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Moderate Activities, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- Number of Participants With the Indicated Responses to the Question of Whether Their Health is Limited in Climbing Stairs, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- Number of Participants With the Indicated Responses to the Question of Whether They Had Accomplished Less Than They Would Like, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- Number of Participants With the Indicated Responses to the Question of How Often They Were Limited in the Kind of Work/Activities, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- Number of Participants With the Indicated Responses to the Question of How Often They Accomplished Less Due to Emotional Problems, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- Number of Participants With the Indicated Responses to the Question of How Often They Did Work Less Carefully Due to Emotional Problems, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- Number of Participants With the Indicated Responses to the Question of to What Degree Does Pain Interfere With Normal Work, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- Number of Participants With the Indicated Responses to the Question of How Often They Felt Calm and Peaceful, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- Number of Participants With the Indicated Responses to the Question of How Often They Have a Lot of Energy, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- Number of Participants With the Indicated Responses to the Question of How Often They Felt Downhearted and Depressed, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- Number of Participants With the Indicated Responses to the Question of How Often They Experience Interference With Social Activities, a Question on the 12-item Short Form Health Survey(Day 1 of a 1-day study)
- FEV1 and FVC, Pre-bronchodilator Spirometry Measures(Day 1 of a 1-day study)
- FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Pre-bronchodilator Spirometry Measures(Day 1 of a 1-day study)
- FEV1 and FVC, Post-bronchodilator Spirometry Measures(Day 1 of a 1-day visit)
- FEV1 Percent Predicted and FEV1/FVC Percent Predicted, Post-bronchodilator Spirometry Measures(Day 1 of a 1-day study)
- Post-bronchodilator Reversibility Measures(Day 1 of a 1-day study)
- Number of Participants Who Responded "Yes" to Respective Questions Regarding Past Illness(Day 1 of a 1-day study)
- Number of Participants Who Responded "Yes" to Respective Questions Regarding Occupational History and Socioeconomic Status(Day 1 of a 1-day study)
- Number of Participants Who Completed the Highest Indicated Education Level or Grade(Day 1 of 1-day study)
- Number of Participants With the Indicated Experience With Tobacco Smoking(Day 1 of 1-day study)
- Number of Participants Who Responded "Yes" When Asked Indicated Questions Regarding Medical History(Day 1 of 1-day study)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
A randomized control trial investigating the effectiveness of three different upper jaw expansion devices in correcting narrow upper jaws in 10-16 year old children.Constricted MaxillaACTRN12617001136392Sydney Dental Hospital60
尚未招募
2 期
A Clinical Study To Evaluate The Therapeutic Effect of Lekhana Basti(Yoga Basti) And Gomutra Hareetaki Orally In Uterine FibroidCTRI/2023/01/048961SRI DHARMASTHALA MANJUNATHESWARA COLLEGE OF AYURVEDA
尚未招募
4 期
Role of Shubhdeep Swasha Hara Pill in management of Shwasa roga (Asthma)CTRI/2020/01/022961Self
尚未招募
4 期
Role Of Shubhdeep Liv-Gud Pill In Fatty Liver (Yakrutdalyodara)CTRI/2020/02/023410Shubhdeep Ayurveda Medical College And Hospital
已完成
不适用
Clinical Pharmacological Study to Investigate the Effects of Mucosta Ophthalmic Suspension UD2% on Ocular Surface Cells in Patients with Dry EyeDry eyeJPRN-UMIN000022629Otsuka Pharmaceutical Co., Ltd.15