NCT02002715

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eosinophilic Bronchitis

Interventions

Type	Name	Description
DRUG	Inhaled budesonide	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

Timeline

• Start date: 2008-03-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2013-12-06
• Last updated: 2019-06-05

Locations

1 site across 1 country: China