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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The First Affiliated Hospital of Guangzhou Medical University
Sponsor:
Information provided by (Responsible Party):
Kefang Lai, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT02002715
First received: December 2, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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 Intervention Phase
Eosinophilic Bronchitis
Drug: Inhaled budesonide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • Day-time and night-time cough symptom total-score changes from baseline to last visit [ Time Frame: week 0,week 4.week 8,week16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • percentage of eosinophil in induced sputum from baseline to last visit [ Time Frame: week 0,week 4,week 8,week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: January 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 2, 2013
Last Updated: December 2, 2013
Health Authority: China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014