Eosinophilic Bronchitis | The Effect of Bronchodilator on Eosinophilic Bronchitis and Cough Variant Asthma
Eosinophilic Bronchitis research study
What is the primary objective of this study?
This study aim is to observe the response to Bambuterol Hydrochloride tablets treatment in subjects with eosinophilic bronchitis . The investigators hypothesize: A few of subjects with EB have some responses to Bambuterol Hydrochloride tablets therapy. Most of subjects with CVA respond well to Bambuterol Hydrochloride tablets therapy
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 with eosinophilic bronchitis 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 with cough variant asthma have positive result in bronchial provocation test. 5. 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 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. 5. Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG. 6. Patients who does not cooperate with us.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Cough Variant Asthma
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:Bambuterol Hydrochloride tabletsBambuterol Hydrochloride tablets(10mg) 3 tablets qd for three days(swallowed by warm water at 0.5-1h after each meal)
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.
Eosinophilic bronchitisBambuterol Hydrochloride tablets 10mg,QN,for 3 days
cough variant asthmaBambuterol Hydrochloride tablets 10mg,QN,for 3 days
Start Date: June 2012
Completed Date: March 2014
Phase: Phase 4
Primary Outcome: Day-time and night-time cough symptom total-score changes from baseline to day 3.
Secondary Outcome: cough sensitivity from baseline to day 3
Study sponsors, principal investigator, and references
Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University