The Mixed Phenotype of Asthma and COPD: the Overlap Syndrome: A Comparison of Asthma Outcomes in Smoking vs Non-smoking Patients With an Incomplete Reversibility of Airway Obstruction (IRAO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Total asthma control questionnaire (ACQ) score
研究概览
简要总结
RATIONALE:
In asthmatic subjects, smoking can lead to several changes in disease characterictics. in smokers of more than 20 pack-years, chronic obstructive pulmonary disease (COPD) can be associated with asthma, also called asthma-COPD overlap syndrome (ACOS). Increasing data support the concept that ACOS is a clinical entity. However, this should be further studied in order to better target therapy.
AIM:
The objective of this study is to evaluate the comparative features of ACOS
METHODS:
This will be a descriptive study comparing the features of the ACOS with the features of asthmatic subjects with an incomplete reversibility of airway obstruction (IRAO).The study will be done over 1 or 2 visits (within a week interval), according to subjects' availability. The visit will include completion of different questionnaires (asthma control asthma quality of life, medical history, exacerbations, etc.), a thoracic examination, allergy skin-prick tests, spirometry and bronchodilator response, lung volumes and compliance measurements, exhaled nitric oxide measurement, blood sampling and a sputum induction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ALL SUBJECTS
- •Subjects aged 45 years and older.
- •Free of any other respiratory condition, except for asthma and/or COPD, which may interfere with the tests.
- •Asthma that requires a baseline treatment with inhaled corticosteroids and/or additional asthma medication.
- •Free of respiratory infection in the 4 weeks preceding the study.
- •No changes in the asthma and COPD-related medications in the 4 weeks preceding the study.
- •If female, not pregnant (or lactating).
- •Able to adhere to study procedures.
- •Able and willing to provide written informed consent to participate in the study, in accordance with international conference on harmonization (ICH) good clinical practice (GCP) requirements.
- •ACOS SUBJECTS
- •Smokers or ex-smokers of at least 20 pack-years.
- •With an IRAO (see definitions section). IRAO SUBJECTS
- •Long-life non-smokers or ex-smokers defined as someone who smoked less than 5 pack-years and who completely stopped smoking for at least 12 months before inclusion in the study.
- •With an IRAO.
排除标准
- •ALL SUBJECTS
- •With COPD without a past diagnosis of asthma.
- •Unstable respiratory or non-respiratory condition.
- •Any active chronic inflammatory disease.
- •Any evidence of malignancy (active and/or treated) within the previous 5 years.
- •Any significant concomitant illness or injury that would interfere with the subject's participation in the study.
- •Any history of bronchial thermoplasty. IRAO SUBJECTS
- •Use of any nicotine containing product within 1 year prior to study entry or a smoking history of > 5 pack-years.
结局指标
主要结局
Total asthma control questionnaire (ACQ) score
时间窗: Baseline
Measurement of asthma control using a 0-6 scale. The questionnaire includes 6 questions. Total score is the mean of the scores from all questions. Total score ranges from 0 to 6. A lower score is better.
次要结局
- Asthma quality of life questionnaire (AQLQ) score(Baseline)
- Spirometry results(Baseline)
- Sputum eosinophil percentage(Baseline)
- Change from baseline total Asthma Control Questionnaire (ACQ) score at one-year follow-up(Baseline to one-year follow-up)
- Concentration of Blood biomarkers(Baseline)
- Number of patients with comorbidities(Baseline)
- Number of asthma exacerbations in the previous year(Baseline)
- Change from baseline number of exacerbations at one-year follow-up(Baseline to one-year follow-up)