Eosinophilic Bronchitis | Therapeutic Effect of Different Treatment Course With Inhaled Corticosteroids in Eosinophilic Bronchitis Patients
Eosinophilic Bronchitis research study
What is the primary objective of this study?
This study aims to observe the therapeutic effect of different treatment course with inhaled corticosteroids in eosinophilic bronchitis patients. The investigators hypothesize: 1. Cough score will be improved after treatment with longer treatment course with inhaled corticosteroids in EB patients. 2. The sputum eosinophil percentage will be decreased and recovered to normal level (Eos%<2.5%) with longer treatment course with inhaled corticosteroids in EB patients. 3. The rate of recurrence after treatment will be decrease with longer treatment course with inhaled corticosteroids in EB patients
Who is eligible to participate?
Inclusion Criteria: 1. Patients who have a history of cough as sole or main symptom lasting more than 8 weeks. 2. Patients whose chest x-ray outcome was normal or without any active focus. 3. Patients who were diagnosed with the result of sputum eosinophil percentage (Eos%) over 2.5%, and the negative result in bronchial provocation test by methacholine inhalation challenge. 4. Patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old). Exclusion Criteria: 1. Patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history ＞10 pack-years or equivalence. 2. Patients with concomitance of GERC (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, ACEI induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction. 3. Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study. 4. Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications. 5. Subjects who have received any therapy in the previous 4 weeks, e.g.corticosteroids ,antihistamines, leukotriene receptor antagonist in previous 4 weeks 6. Subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia. 7. Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Inhaled budesonideinhaled Budesonide 2puff Q12h,total 400µg/day for 4 weeks inhaled Budesonide 2puff Q12h,total 400µg/day for 8 weeks inhaled Budesonide 2puff Q12h,total 400µg/day for 16 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Inhaled budesonide for 4 weeksinhaled Budesonide 100µg , 2puff Q12h for 4 weeks
Inhaled budesonide for 8 weeksinhaled Budesonide 100µg , 2puff Q12h for 8 weeks
Inhaled budesonide for 16 weeksinhaled Budesonide 100µg , 2puff Q12h for 8 weeks
Start Date: January 2012
Completed Date: February 2014
Phase: Phase 4
Primary Outcome: Day-time and night-time cough symptom total-score changes from baseline to last visit
Secondary Outcome: percentage of eosinophil in induced sputum from baseline to last visit
Study sponsors, principal investigator, and references
Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University