Trial record 1 of 6 for:
Open Studies | "Antitussive Agents"
Effects of Su-Huang Antitussive Capsule on Cough Variant Asthma
Verified November 2012 by The First Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
First received: April 24, 2012
Last updated: November 15, 2012
Last verified: November 2012
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.
Drug: Su-Huang antitussive capsule
Drug: Sugar pill
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||Randomised, Double-blinded, Placebo-Controlled Study of Therapeutic Effect of Su-Huang Antitussive Capsule on Cough Variant Asthma(CVA)
Primary Outcome Measures:
- Day-time and night-time cough symptom total-score changes from baseline to visit 3 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
Active Comparator: Monotherapy
Monotherapy with Su-Huang antitussive capsule
Drug: Su-Huang antitussive capsule
Su-Huang antitussive capsule (0.45g) 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal)
Placebo Comparator: Sugar pill
Monotherapy with placebo
Drug: Sugar pill
Sugar pill 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal)
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
- Patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
- There is evidence that bronchodilator treatment* is efficient for cough symptom (symptom score improved 1 at least).
- Patients whose chest x-ray outcome was normal or without any active focus.
- Patients who was aged from 18 years old (≥ 18 years old ) to 65 years old (≤ 75 years old).
- Patients demonstrate FEV1/FVC ＜70% in lung function test. FEV1 stands for forced expiratory volume in 1 second, FVC stands for forced vital capacity.
- 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.
- 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.
- Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
- Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
- Subjects who have received any therapy in the previous seven days, e.g. long-acting β2 agonist, theophylline sustained release.
- Subjects who have received oral/ inhaled/systematic corticosteroid in the previous 4 weeks.
- 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.
- Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584804
|Guangzhou Institute of Respiratory Disease
|Guangzhou, Guangdong, China, 520120 |
|Contact: Kefang Lai, PHD firstname.lastname@example.org |
|Principal Investigator: Kefang Lai, PHD |
The First Affiliated Hospital of Guangzhou Medical University
||Mengfeng Li, MD
||Sun Yat-sen University
No publications provided
||Kefang Lai, professor, The First Affiliated Hospital of Guangzhou Medical University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 24, 2012
||November 15, 2012
||China: Food and Drug Administration
Keywords provided by The First Affiliated Hospital of Guangzhou Medical University:
Su Huang antitussive capsule
Cough variant asthma
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Chlorpheniramine, phenylpropanolamine drug combination
Respiratory System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Agents
Peripheral Nervous System Agents