Therapeutic Effect of Different Treatment Course With Inhaled Corticosteroids in Eosinophilic Bronchitis Patients
Condition: Eosinophilic Bronchitis
MeSH terms: Bronchitis; Acute Disease
Study type: Interventional
Phase: Phase 4

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 description: 
      Study groups:

      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):

           A physical examination was to be performed. All laboratory tests results are obtained to
           determine whether patients meet the inclusion/exclusion criteria. Enrolled patients are
           randomly divided into three groups with inhaled budesonide 200 µg twice daily via a
           turbohaler for 4 weeks, 8 weeks and 16 weeks respectively and given the Diary Card.

        3. During Treatment (Week 0 to Week 4/8/16,every 4 weeks):

           Patients were to take study medication for 4 weeks in 4-week group,8 weeks in 8-week
           group,16 weeks in 16-week group. All patient are followed-up every 4 weeks and completed
           Diary Card for 7 days in the last week of treatment.

        4. Third Visit (Visit 3, Week 4/8/16):

           A physical examination were to be performed. The Diary Card were collected and reviewed.
           Adverse events, secondary complications, concurrent medication will be
           recorded.Hypertonic saline induced sputum samples for cell differential is taken from
           enrolled patients.Blood samples for routine clinical laboratory tests (haematology and
           biochemistry) were obtained

        5. Follow-up visits were conducted after 1 year and whenever recurrence of cough :Cough
           symptom score,visual analogue scale (VAS), spiromery and induced sputum for cell
           differential is taken from enrolled patients.
    

Intervention name(s): Inhaled budesonide
Intervention type(s): Drug
Intervention description(s): inhaled Budesonide 2puff Q12h,total 400µg/day for 4 weeks inhaled Budesonide 2puff Q12h,total 400µg/day for 8 weeks inhaled Budesonide 2puff Q12h,total 400µg/day for 16 weeks
Other intervention name(s): Budesonide Powder for Inhalation
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eosinophilic bronchitis; inhaled corticosteroids; therapeutic effect