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Effects of Su-Huang Antitussive Capsule on Cough Variant Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01584804
Recruitment Status : Unknown
Verified November 2012 by Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : April 25, 2012
Last Update Posted : November 19, 2012
Information provided by (Responsible Party):
Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Su-Huang antitussive capsule Drug: Sugar pill Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomised, Double-blinded, Placebo-Controlled Study of Therapeutic Effect of Su-Huang Antitussive Capsule on Cough Variant Asthma(CVA)
Study Start Date : June 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : August 2013

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Day-time and night-time cough symptom total-score changes from baseline to visit 3 [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01584804

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Contact: Kefang Lai, PhD 8620 83062893

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China, Guangdong
Guangzhou Institute of Respiratory Disease Recruiting
Guangzhou, Guangdong, China, 520120
Contact: Kefang Lai, PHD   
Principal Investigator: Kefang Lai, PHD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
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Study Chair: Mengfeng Li, MD Sun Yat-sen University

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Responsible Party: Kefang Lai, professor, The First Affiliated Hospital of Guangzhou Medical University Identifier: NCT01584804     History of Changes
Other Study ID Numbers: 2003L03253
First Posted: April 25, 2012    Key Record Dates
Last Update Posted: November 19, 2012
Last Verified: November 2012

Keywords provided by Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University:
Su Huang antitussive capsule
Cough variant asthma

Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Antitussive Agents
Chlorpheniramine, phenylpropanolamine drug combination
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents