Early Diagnosis and Treatment of Undiagnosed COPD or Asthma: The UCAP 2 Trial - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).
研究概览
简要总结
Our research group has found that Canadians with undiagnosed asthma or chronic obstructive pulmonary disease (COPD) have increased respiratory symptoms and worse health-related quality of life.
The investigators recently developed and validated an on-line questionnaire to accurately identify these symptomatic, undiagnosed individuals.
The investigators will advertise in the community asking individuals to complete the on-line questionnaire at home, at their leisure, to determine if they are at risk of asthma or COPD. Those at risk will be invited to participate in our randomized, controlled clinical trial to determine if guidelines-based treatment of newly discovered undiagnosed asthma or COPD will improve their quality of life and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals at least 18 years old
- •Individuals must be symptomatic with respiratory symptoms
- •Individuals must complete the UCAP-Q questionnaire and score a ≥ 6% probability of having either asthma or COPD.
- •Individuals who have given written informed consent to participate in this trial in accordance with local regulations;
- •Individual must be able to perform pre and post bronchodilator spirometry to measure lung function
- •Additional Inclusion Criteria for the Randomized Controlled Trial (RCT):
- •Individuals who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose forced expiratory volume in 1 second (FEV1) improves by > 12% and 200 ml after bronchodilator and COPD will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to participate in the RCT.
排除标准
- •Individuals who report a previous diagnosis of asthma, COPD, history of lung cancer, bronchiectasis, interstitial lung disease, cystic fibrosis or other significant diagnosed lung disease.
- •Individuals currently under the care of a respirologist
- •Individuals currently using inhaled corticosteroids or long-acting bronchodilators.
- •Individuals with history of myocardial infarction, stroke, aortic or cerebral aneurysm, or detached retina or eye surgery within the past 3 months (spirometry is contraindicated)
- •Individuals who are in the third trimester of pregnancy
- •Individuals involved in another interventional trial
结局指标
主要结局
Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).
时间窗: 12 weeks
The change in disease-specific quality of life will be expressed as the total St. George's Respiratory Questionnaire score at 12 weeks minus the score on the day of randomization. This questionnaire includes 3 domains: symptoms (distress caused by specific respiratory symptoms); activity (physical activities that cause or are limited by breathlessness); and impact (social and psychological effects of the respiratory disease). A total change of - 4 points in the SGRQ total score has been established as the minimal clinically important difference (MCID) for this questionnaire. Higher scores indicate poor health status.
次要结局
- Change in dyspnea as assessed by The Baseline and Transitional Dyspnea Indexes(12 weeks)
- Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)(12 weeks)
- Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.(12 weeks)
- Changes in absenteeism and presenteeism as assessed by the Work Productivity and Activity Impairment Questionnaire (WPAI)(12 weeks)
- Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire(12 weeks)
- Differences between groups in patient-initiated healthcare utilization events for respiratory illness over the 12-week trial period.(12 weeks)