Role of Airway Tissue Temperature in Asthma Exacerbation
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Airway tissue temperature
研究概览
简要总结
Airway irritation, cough and bronchial spasm are common symptoms in patients with airway inflammatory diseases such as asthma. The primary focus of this exploratory study is to determine if there is an increase in tissue temperature in airway mucosa during asthma exacerbation. The results of this study will bring a better understanding of the potential involvement of an increase in airway mucosa temperature in the pathogenesis of various symptoms in these patients. The finding should help to advance the development of new therapeutic strategies for these debilitating diseases.
详细描述
A total of eight participants will be enrolled into this study. We will take direct measurements of bronchial mucosa temperature. This can only be tested accurately in asthma participants because anesthesia is known to lower the body temperature. The proposed study using and experimental procedure called a segmental bronchoprovocation challenge with allergen in asthmatic patients offers a unique approach to test our hypothesis.
Individuals enrolled into this study will participate for eight weeks and will take part in four visits each estimated to last 2 and 8 hours. Participants will also participant in one follow-up phone call following Test day 2.
Patients with asthma and healthy participants will be recruited to participate in this study through advertisement postings in the Kentucky Clinic and/or the University of Kentucky Hospital as well as on main campus. The study will also be added to a website using the same posting.
Patients with asthma who have been prescribed for a diagnostic or therapeutic bronchoscopy procedure at the UK Pulmonary Clinic will be identified and recruited by qualified physicians in that clinic. The medical history and records of the patients will be made available which includes data form a complete spirometry test and other clinical tests, physical examination, smoking history, symptoms, current medication use, drug allergies, laboratory and imaging data.
After eligible patients are identified and meet proper inclusion criteria, informed consent will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-60 years of age
- •Diagnosis of well-controlled airway allergy with mild-intermittent asthma (a stable clinical condition with good asthma control) and demonstrating an allergen-specific airway response to inhaled allergen provocation.
- •Pre-albuterol forced expiratory volume in the first second (FEV1) of >70% of the predicted value.
- •Skin test positive to house dust mite, ragweed or cat hair.
- •At least a 20% decrease in FEV1 during the immediate response following inhaled antigen challenge.
- •Competent to understand and willing to grant written informed consent.
排除标准
- •Inability to perform pulmonary function testing.
- •History of any lung disease or disorder other than asthma.
- •Major health problems such as autoimmune disease, heart disease, coronary artery disease, type I or type II diabetes, or uncontrolled hypertension.
- •Pre-existing chronic infectious disease.
- •Medication that is taken for other than for asthma, allergies or contraception.
- •Inhaled corticosteroids or oral corticosteroids within 1 month of screening.
- •Upper and lower respiratory infection within 1 month of screening.
- •Unstable asthma as indicated by self report of increased symptoms or increased beta-agonist use over the 2 weeks preceding the screening visit.
- •Pregnant or lactating females.
- •History of smoking.
- •History of noncompliance with medical regiments or subjects who are considered unreliable.
- •Use of anti-platelet (i.e., aspirin, clopidogrel, etc) or anti-coagulant(coumadin, heparin, Xarelto®, etc) medication 5 days prior to bronchoscopy.
- •It is required that the subjects undergoing bronchoscopy are not on any anti-platelets (such as aspirin, clopidogrel, etc.) or anticoagulants (such as coumadin, heparin, Xarelto®, etc.) at least 5 days prior to the bronchoscopy. As such, subjects receiving any of these medications will be excluded from the study.
结局指标
主要结局
Airway tissue temperature
时间窗: Immediately during experimental procedure (up to 10 minutes)
Direct measurements of the airway mucosal temperature will be performed before and at ten minutes after the SBP-Ag challenge. By maneuvering the control knob of the bronchoscope, the blunted tip of the probe will be gently pressed against the airway mucosa at 5-6 different positions in segmental and sub-segmental bronchi, each for five to ten seconds. The entire protocol of the temperature measurement will require no more than 5 minutes to complete.
次要结局
未报告次要终点
研究者
Lu Yuan Lee
Principal Investigator
University of Kentucky