The Effect of Bronchodilator on Eosinophilic Bronchitis and Cough Variant Asthma

NCT02002754 | Unknown Phase 4 DMC

• 1 other identifier: cough2009
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Eosinophilic Bronchitis; Cough Variant Asthma

Keywords

eosinophilic bronchitis; cough variant asthma; bronchodilator

Outcome Measures

Primary Outcomes (1)

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

  three days

Secondary Outcomes (1)

• cough sensitivity from baseline to day 3

  three days

Study Arms (2)

Eosinophilic bronchitis

ACTIVE COMPARATOR

Bambuterol Hydrochloride tablets 10mg,QN,for 3 days

Drug: Bambuterol Hydrochloride tablets

cough variant asthma

ACTIVE COMPARATOR

Bambuterol Hydrochloride tablets 10mg,QN,for 3 days

Drug: Bambuterol Hydrochloride tablets

Interventions

Bambuterol Hydrochloride tablets DRUG

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

Eosinophilic bronchitis; cough variant asthma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 520120, China

RECRUITING

MeSH Terms

Conditions

Cough-Variant Asthma

Interventions

bambuterol

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Lai Kefang, PhD

CONTACT

8620 83062893; kelai@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: June 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

CN (1)