Clinical Trial: Therapeutic Effect of Different Treatment Course With Inhaled Corticosteroids in Eosinophilic Bronchitis Patients

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomised, Open-label, Parallel-group Study of Therapeutic Effect of Different Treatment Course With Inhaled Corticosteroids in Eosinophilic Bronchitis Patients

Brief Summary:

This study aims to observe the therapeutic effect of different treatment course with inhaled corticosteroids in eosinophilic bronchitis patients.

The investigators hypothesize:

1. Cough score will be improved after treatment with longer treatment course with inhaled corticosteroids in EB patients.
2. The sputum eosinophil percentage will be decreased and recovered to normal level (Eos%<2.5%) with longer treatment course with inhaled corticosteroids in EB patients.
3. The rate of recurrence after treatment will be decrease with longer treatment course with inhaled corticosteroids in EB patients

Detailed Summary:

Study groups:

90 patients diagnosed with EB will be randomised into three groups as follows: Group 1(4-week treatment group):The patients with eosinophilic bronchitis received Pulmicourt Turbuhaler (Budesonide 100µg) 2puff Q12h for 4 weeks.

Group 2(8-week treatment group):The patients with eosinophilic bronchitis received Pulmicourt Turbuhaler (Budesonide 100µg) 2puff Q12h for 8 weeks.

Group 3(16-week treatment group):The patients with eosinophilic bronchitis received Pulmicourt Turbuhaler (Budesonide 100µg) 2puff Q12h for 16 weeks.

The study will be divided into following phases:

1. First Visit (Visit 1, day -3):

   A full medical history and physical examination to be undertaken to determine whether patients meet the inclusion/exclusion criteria.

   After the informed consent has been signed, the following samples are obtained from all patients: blood samples for routine clinical laboratory tests (haematology, biochemistry and chest x-ray). A urine pregnancy test will be performed in women of childbearing potential.

   Bronchial provocation test by methacholine inhalation are performed to determined whether it presences of bronchial non-specific hyper-responsiveness. Hypertonic saline induced sputum samples for cell differential is taken to determine whether it esixt eosinophilic airway inflammation.

2. Second Visit (Visit 2, Week 0):

   Same as current
   
   

   Current Secondary Outcome: percentage of eosinophil in induced sputum from baseline to last visit [ Time Frame: week 0,week 4,week 8,week 16 ]
   
   

   Original Secondary Outcome: Same as current
   
   Information By: The First Affiliated Hospital of Guangzhou Medical University
   

   Dates:
   Date Received: December 2, 2013
   Date Started: January 2012
   Date Completion: February 2014
   Last Updated: December 2, 2013
   Last Verified: December 2013