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

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

Study Overview

• Status: Completed
• Conditions: Eosinophilic Bronchitis
• Intervention / Treatment: Drug: Inhaled budesonide

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 520120
      • Guangzhou Institute of Respiratory Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients who have a history of cough as sole or main symptom lasting more than 3 weeks.
2. Patients whose chest x-ray outcome was normal or without any active focus.
3. Patients 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 who was aged from 18 years old (≥ 18 years old ) to 75 years old (≤ 75 years old).

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 known or suspected to be hypersensitive to any component of the study medication or relief medications.
5. Subjects who have received any therapy in the previous 4 weeks, e.g.corticosteroids ,antihistamines, leukotriene receptor antagonist in previous 4 weeks
6. 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.

7. Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inhaled budesonide for 4 weeks; inhaled Budesonide 100µg , 2puff Q12h for 4 weeks	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; Other Names: Budesonide Powder for Inhalation
Active Comparator: Inhaled budesonide for 8 weeks; inhaled Budesonide 100µg , 2puff Q12h for 8 weeks	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; Other Names: Budesonide Powder for Inhalation
Active Comparator: Inhaled budesonide for 16 weeks; inhaled Budesonide 100µg , 2puff Q12h for 16 weeks	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; Other Names: Budesonide Powder for Inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary outcome was the relapse rate of eosinophilic bronchitis in one year.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
change in percentage of eosinophil in induced sputum from baseline to post-treatment	week 0,week 4,week 8,week 16
change in Cough visual analogue scale (VAS) and Cough Symptom Score (CSS) from baseline to post-treatment	week 0,week 4,week 8,week 16

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

General Publications

• Zhan W, Tang J, Chen X, Yi F, Han L, Liu B, Luo W, Chen Q, Lai K. Duration of treatment with inhaled corticosteroids in nonasthmatic eosinophilic bronchitis: a randomized open label trial. Ther Adv Respir Dis. 2019 Jan-Dec;13:1753466619891520. doi: 10.1177/1753466619891520.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2008
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: December 2, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: therapeutic effect; inhaled corticosteroids; eosinophilic bronchitis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Acute Disease; Bronchitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: cough001