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

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ClinicalTrials.gov Identifier: NCT02002715
Recruitment Status : Unknown
Verified December 2013 by Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : December 6, 2013
Last Update Posted : December 6, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Eosinophilic Bronchitis Drug: Inhaled budesonide Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised, Open-label, Parallel-group Study of Therapeutic Effect of Different Treatment Course With Inhaled Corticosteroids in Eosinophilic Bronchitis Patients
Study Start Date : January 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide
U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Budesonide Powder for Inhalation
Active Comparator: Inhaled budesonide for 16 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 Name: Budesonide Powder for Inhalation


Outcome Measures

Primary Outcome Measures :
  1. Day-time and night-time cough symptom total-score changes from baseline to last visit [ Time Frame: week 0,week 4.week 8,week16 ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients who have a history of cough as sole or main symptom lasting more than 8 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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002715


Contacts
Contact: Kefang Lai, PhD 8620-83062893 klai@163.com

Locations
China, Guangdong
Guangzhou Institute of Respiratory Disease Recruiting
Guangzhou, Guangdong, China, 520120
Principal Investigator: Kefang Lai, PHD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
More Information

Responsible Party: Kefang Lai, professor, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02002715     History of Changes
Other Study ID Numbers: cough001
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013

Keywords provided by Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University:
eosinophilic bronchitis
inhaled corticosteroids
therapeutic effect

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists