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Effects of Su-Huang Antitussive Capsule on Cough Variant Asthma

This study is currently recruiting participants.
Verified November 2012 by The First Affiliated Hospital of Guangzhou Medical University
Sponsor:
Information provided by (Responsible Party):
Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01584804
First received: April 24, 2012
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Asthma
Drug: Su-Huang antitussive capsule
Drug: Sugar pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

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: 60
Study Start Date: June 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584804

Contacts
Contact: Kefang Lai, PhD 8620 83062893 klai@163.com

Locations
China, Guangdong
Guangzhou Institute of Respiratory Disease Recruiting
Guangzhou, Guangdong, China, 520120
Contact: Kefang Lai, PHD       klai@163.com   
Principal Investigator: Kefang Lai, PHD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
Study Chair: Mengfeng Li, MD Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Kefang Lai, professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01584804     History of Changes
Other Study ID Numbers: 2003L03253
Study First Received: April 24, 2012
Last Updated: November 15, 2012
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 17, 2014