CClinicalTrials.gg
Status unknownNCT02002754Updated Dec 6, 2013

The Effect of Bronchodilator on Eosinophilic Bronchitis and Cough Variant Asthma

A Phase 4 interventional study of Bambuterol Hydrochloride tablets in Eosinophilic Bronchitis and Cough Variant Asthma, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-12-06.

Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Eosinophilic Bronchitis
  • Cough Variant Asthma

Keywords

  • eosinophilic bronchitis
  • cough variant asthma
  • bronchodilator
03

In context

Bronchitis

268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.

This study's planned enrollment of 45 is below the median of 120 across 184 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Active comparator
    Eosinophilic bronchitis

    Bambuterol Hydrochloride tablets 10mg,QN,for 3 days

    Drug: Bambuterol Hydrochloride tablets

  • Active comparator
    cough variant asthma

    Bambuterol Hydrochloride tablets 10mg,QN,for 3 days

    Drug: Bambuterol Hydrochloride tablets

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)

06

What researchers measure

Primary outcomes

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

    Time frame: three days

Secondary outcomes

  1. cough sensitivity from baseline to day 3

    Time frame: three days

07

Study locations

1 of 1 sites recruiting
  • Guangzhou Institute of Respiratory Disease
    Guangzhou, Guangdong 520120, China
    • Kefang Lai, PHD · Contact · klai@163.com
    • Kefang Lai, PHD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02002754
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Responsible party
Kefang Lai (professor, The First Affiliated Hospital of Guangzhou Medical University) — Principal investigator
First posted
Dec 6, 2013
Start date
Jun 2012
Primary completion
Mar 2014 (estimated)
Completion
Mar 2014 (estimated)
Last update
Dec 6, 2013

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion