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The Effect of Bronchodilator on Eosinophilic Bronchitis and Cough Variant Asthma

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ClinicalTrials.gov Identifier: NCT02002754
Recruitment Status : Unknown
Verified December 2013 by Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : December 6, 2013
Last Update Posted : December 6, 2013
Sponsor:
Information provided by (Responsible Party):
Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Eosinophilic Bronchitis Cough Variant Asthma Drug: Bambuterol Hydrochloride tablets Phase 4

Detailed Description:

Study groups:

45 patients with chronic cough will be collected and two groups will formed based on diagnosis as follows:

Group 1: EB group The patients with eosinophilic bronchitis received Bambuterol Hydrochloride tablets 10mg Q24 for three days .

Group 2: CVA group The patients with cough variant asthma received Bambuterol Hydrochloride tablets 10mg Q24 for three days .

Observe the response to Bambuterol Hydrochloride tablets treatment three days later and compare the effective rate of patients with EB and CVA. Then the study will be over.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised, Open-label, Parallel-group Study of the Response to Bronchodilator Treatment in Subjects With Eosinophilic Bronchitis and the Mechanism of Varied Responses to Bronchodilator Treatment.
Study Start Date : June 2012
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Eosinophilic bronchitis
Bambuterol Hydrochloride tablets 10mg,QN,for 3 days
 Drug: Bambuterol Hydrochloride tablets
Bambuterol Hydrochloride tablets(10mg) 3 tablets qd for three days(swallowed by warm water at 0.5-1h after each meal)
Active Comparator: cough variant asthma
Bambuterol Hydrochloride tablets 10mg,QN,for 3 days
 Drug: Bambuterol Hydrochloride tablets
Bambuterol Hydrochloride tablets(10mg) 3 tablets qd for three days(swallowed by warm water at 0.5-1h after each meal)


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

Secondary Outcome Measures :
  1. cough sensitivity from baseline to day 3 [ Time Frame: three days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
  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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02002754


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

Locations
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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
More Information
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Responsible Party: Kefang Lai, professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02002754    
Other Study ID Numbers: cough2009
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013
Keywords provided by Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University:
eosinophilic bronchitis
cough variant asthma
bronchodilator
Additional relevant MeSH terms:
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Bronchitis
Asthma
Cough
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
 Signs and Symptoms, Respiratory
Respiratory Tract Infections
Infections
Disease Attributes
Pathologic Processes
Bambuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents