The Effect of Bronchodilator on Eosinophilic Bronchitis and Cough Variant Asthma

NCT ID: NCT02002754

Last Updated: 2013-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Eosinophilic Bronchitis Cough Variant Asthma

Keywords

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eosinophilic bronchitis cough variant asthma bronchodilator

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Eosinophilic bronchitis

Bambuterol Hydrochloride tablets 10mg,QN,for 3 days

Group Type ACTIVE_COMPARATOR

Bambuterol Hydrochloride tablets

Intervention Type DRUG

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

cough variant asthma

Bambuterol Hydrochloride tablets 10mg,QN,for 3 days

Group Type ACTIVE_COMPARATOR

Bambuterol Hydrochloride tablets

Intervention Type DRUG

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

Interventions

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Bambuterol Hydrochloride tablets

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Kefang Lai

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lai Kefang, PhD

Role: CONTACT

Phone: 8620 83062893

Email: [email protected]

Facility Contacts

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Kefang Lai, PHD

Role: primary

Other Identifiers

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cough2009

Identifier Type: -

Identifier Source: org_study_id