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

NCT02002715 | Completed Phase 4 DMC

• 1 other identifier: cough001
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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. 1.Cough score will be improved after treatment with longer treatment course with inhaled corticosteroids in EB patients.
2. 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. 3.The rate of recurrence after treatment will be decrease with longer treatment course with inhaled corticosteroids in EB patients

Conditions

Eosinophilic Bronchitis

Keywords

eosinophilic bronchitis; inhaled corticosteroids; therapeutic effect

Outcome Measures

Primary Outcomes (1)

• The primary outcome was the relapse rate of eosinophilic bronchitis in one year.

  1 year

Secondary Outcomes (2)

• 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

Study Arms (3)

Inhaled budesonide for 4 weeks

ACTIVE COMPARATOR

inhaled Budesonide 100µg , 2puff Q12h for 4 weeks

Drug: Inhaled budesonide

Inhaled budesonide for 8 weeks

ACTIVE COMPARATOR

inhaled Budesonide 100µg , 2puff Q12h for 8 weeks

Drug: Inhaled budesonide

Inhaled budesonide for 16 weeks

ACTIVE COMPARATOR

inhaled Budesonide 100µg , 2puff Q12h for 16 weeks

Drug: Inhaled budesonide

Interventions

Inhaled budesonide DRUG

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

Also known as: Budesonide Powder for Inhalation

Inhaled budesonide for 16 weeks; Inhaled budesonide for 4 weeks; Inhaled budesonide for 8 weeks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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.
• Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
• Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
• Subjects who have received any therapy in the previous 4 weeks, e.g.corticosteroids ,antihistamines, leukotriene receptor antagonist in previous 4 weeks
• 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.
• Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 520120, China

Location

Related Publications (1)

• 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.

  PMID: 31847717 DERIVED

MeSH Terms

Interventions

Inhalation

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: March 1, 2008
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

CN (1)