Effect of Allergic Phenotype on Respiratory Sypmtoms And Exacerbations in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To estimate prevalance of sensitivity to various allergens through absolute eosinophil count , Serum IgE and skin prick test in patients of COPD
研究概览
简要总结
Introduction
• Chronic Obstructive Pulmonary Disease (COPD) is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.
• Cigarette smoking is a key environmental risk factor for COPD. Cigarette smokers have a higher prevalence of respiratory symptoms and lung function abnormalities, a greater annual rate of decline in FEV1, and a greater COPD mortality rate than non-smokers
• Wood, animal dung, crop residues, and coal, typically burned in open fires or poorly functioning stoves, may lead to very high levels of household air pollution which is associated with COPD.
• Atopy coming from the greek atopos, meaning “out of place “, refers to the hereditary predisposition to produce immunoglobulin E (Ig E) against common environmental allergens.
• Allergic sensitization has been shown to be a significant predictor of a faster rate of lung function decline and allergen exposure in sensitized individuals may provoke neutrophilic bronchial inflammation, similar to the inflammation seen in airways of patients with COPD.
• However, whether allergy worsens respiratory symptoms in patients with COPD remains unknown.
Why this study is essential?
• Only 10–15% of smokers go on to develop chronic obstructive pulmo-nary disease (COPD). The reasons for this are likely complex and relate primarily to three factors: genetic susceptibility ,dose and timing of exposure, and interactions between smoking and other environmental factors of interest in causing the disease.
• International chronic obstructive pulmonary disease (COPD) guidelines such as the Global Initiative for Chronic Obstructive Lung Disease (GOLD) make no recommendations for allergy diagnosis or treatment. This absence of recommendations may be appropriate given the lack of available evidence.
• The goal of this study is to consider the epidemiologic data that atopy defined as immediate type II hypersensitivity, and not as clinical asthma, is a risk factor for the development of chronic obstructive lung disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with FEVI/FVC less than 70% post bronchodilator irreversibility, diagnosed as COPD on the basis of spirometry , radiological profile(bilateral hyperinflated lung) will be considered.
- •Patients between 30 to 70 years of age group Patients ready to give informed consent for inclusion in the study and skin prick test.
排除标准
- •Patient on oral glucocorticosteroids greater than 4weeks in 6 month duration Patients having history of dermatography.
- •Patients on immunosuppresive medication,patients on monoclonal antibodies like omalizumab,patient on immunoglobulin therapy and patient taking anti histaminic drugs.
- •Patient with past history of severe allergic reactions and anaphylaxis.
- •Patient having active tuberculosis infection.
- •Pregnant women.
结局指标
主要结局
To estimate prevalance of sensitivity to various allergens through absolute eosinophil count , Serum IgE and skin prick test in patients of COPD
时间窗: 15 months
To assess correlation between allergen positivity and various respiratory symptoms in COPD patients
时间窗: 15 months
次要结局
- To assess gender wise prevalence of sensitivity to various allergens.(To study various aspect of patient profile like occupation, family history, medications used)
研究者
Dr Pragati Tyagi
Department of Respiratory Medicine Sir T Hospital campus Bhavnagar