Asthma | Effects of Su-Huang Antitussive Capsule on Cough Variant Asthma
Asthma research study
What is the primary objective of this study?
This study aims to observe the therapeutic effect of Su-Huang antitussive capsule on cough variant asthma. The investigators hypothesize: Cough score and cough reflex sensitivity will be improved after treatment with Su-Huang antitussive capsule.
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, often irritating cough more cough at night. 2. Patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge. 3. There is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least). 4. Patients whose chest x-ray outcome was normal or without any active focus. 5. Patients who was aged from 18 years old (≥ 18 years old ) to 65 years old (≤ 75 years old). Exclusion Criteria: 1. Patients demonstrate FEV1/FVC ＜70% in lung function test. FEV1 stands for forced expiratory volume in 1 second, FVC stands for forced vital capacity. 2. 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. 3. 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. 4. Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study. 5. Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications. 6. Subjects who have received any therapy in the previous seven days, e.g. long-acting β2 agonist, theophylline sustained release. 7. Subjects who have received oral/ inhaled/systematic corticosteroid in the previous 4 weeks. 8. 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. 9. 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:Su-Huang antitussive capsuleSu-Huang antitussive capsule (0.45g) 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal)
Drug:Sugar pillSugar pill 3 capsules Tid for 2 weeks (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.
MonotherapyMonotherapy with Su-Huang antitussive capsule
Sugar pillMonotherapy with placebo
Start Date: June 2012
Completed Date: August 2013
Phase: Phase 4
Primary Outcome: Day-time and night-time cough symptom total-score changes from baseline to visit 3
Secondary Outcome: Cough reflex sensitivity changes in 2 groups at baseline and visit 3. Cell differential changes in hypertonic saline induced sputum in 2 groups at baseline and visit3.
Study sponsors, principal investigator, and references
Principal Investigator: Mengfeng Li, MD
Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University