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The Effect of Bronchodilator on Eosinophilic Bronchitis and Cough Variant Asthma

Primary Purpose

Eosinophilic Bronchitis, Cough Variant Asthma

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Bambuterol Hydrochloride tablets

About this trial

This is an interventional treatment trial for Eosinophilic Bronchitis focused on measuring eosinophilic bronchitis, cough variant asthma, bronchodilator

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who have a history of cough as sole or main symptom lasting more than 8 weeks.
Patients whose chest x-ray outcome was normal or without any active focus.
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.
Patients with cough variant asthma have positive result in bronchial provocation test.
Patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).

Exclusion Criteria:

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 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.
Patients who does not cooperate with us.

Sites / Locations

Guangzhou Institute of Respiratory DiseaseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Eosinophilic bronchitis

cough variant asthma

Arm Description

Bambuterol Hydrochloride tablets 10mg,QN,for 3 days

Outcomes

Primary Outcome Measures

Day-time and night-time cough symptom total-score changes from baseline to day 3.

Secondary Outcome Measures

cough sensitivity from baseline to day 3

Full Information

NCT ID

NCT02002754

First Posted

December 2, 2013

Last Updated

December 5, 2013

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02002754

Brief Title

The Effect of Bronchodilator on Eosinophilic Bronchitis and Cough Variant Asthma

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 Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital of Guangzhou Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eosinophilic Bronchitis, Cough Variant Asthma

Keywords

eosinophilic bronchitis, cough variant asthma, bronchodilator

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Eosinophilic bronchitis

Arm Type

Active Comparator

Arm Description

Bambuterol Hydrochloride tablets 10mg,QN,for 3 days

Arm Title

cough variant asthma

Arm Type

Active Comparator

Arm Description

Bambuterol Hydrochloride tablets 10mg,QN,for 3 days

Intervention Type

Drug

Intervention Name(s)

Bambuterol Hydrochloride tablets

Intervention Description

Bambuterol Hydrochloride tablets(10mg) 3 tablets qd for three days(swallowed by warm water at 0.5-1h after each meal)

Primary Outcome Measure Information:

Title

Day-time and night-time cough symptom total-score changes from baseline to day 3.

Time Frame

three days

Secondary Outcome Measure Information:

Title

cough sensitivity from baseline to day 3

Time Frame

three days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who have a history of cough as sole or main symptom lasting more than 8 weeks. Patients whose chest x-ray outcome was normal or without any active focus. 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. Patients with cough variant asthma have positive result in bronchial provocation test. Patients who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old). Exclusion Criteria: 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 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. Patients who does not cooperate with us.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lai Kefang, PhD

Phone

8620 83062893

kelai@163.com

Facility Information:

Facility Name

Guangzhou Institute of Respiratory Disease

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

520120

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kefang Lai, PHD

klai@163.com

First Name & Middle Initial & Last Name & Degree

Kefang Lai, PHD

12. IPD Sharing Statement

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The Effect of Bronchodilator on Eosinophilic Bronchitis and Cough Variant Asthma

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