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The Effect of Bronchodilator on Eosinophilic Bronchitis and Cough Variant Asthma

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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02002754
Enrollment
45
Registered
2013-12-06
Start date
2012-06-30
Completion date
2014-03-31
Last updated
2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough Variant Asthma, Eosinophilic Bronchitis

Keywords

eosinophilic bronchitis, cough variant asthma, bronchodilator

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.

Interventions

DRUGBambuterol Hydrochloride tablets

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

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
cough sensitivity from baseline to day 3three days

Countries

China

Contacts

Primary ContactLai Kefang, PhD
kelai@163.com8620 83062893

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026