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Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Budesonide
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of COPD or asthma
  • a ratio of prebronchodilator FEV1 to forced vital capacity (FVC) equal to or less than 0.70
  • postbronchodilator FEV1 > or = 50% predicted

Exclusion Criteria:

  • Exacerbation
  • systemic corticosteroids
  • DM, HIV and autoimmune disease
  • immunosuppressive therapy

Sites / Locations

  • Kittipong Maneechotesuwan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

stable COPD

Asthma

Arm Description

Postbronchodilator FEV1> or = 50% predicted

Postbronchodilator FEV1 > or = 50% predicted

Outcomes

Primary Outcome Measures

Sputum IL-8, IL-17

Secondary Outcome Measures

The expression of NF-kappa B in sputum macrophages

Full Information

First Posted
December 16, 2008
Last Updated
September 10, 2013
Sponsor
Mahidol University
Collaborators
National Science and Technology Development Agency, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT00826163
Brief Title
Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Innate Immune Responses in Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
Collaborators
National Science and Technology Development Agency, Thailand

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stable COPD
Arm Type
Active Comparator
Arm Description
Postbronchodilator FEV1> or = 50% predicted
Arm Title
Asthma
Arm Type
Sham Comparator
Arm Description
Postbronchodilator FEV1 > or = 50% predicted
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Rhinocort
Intervention Description
Inhaled budesonide 400 mcg twice a day for 2 weeks
Primary Outcome Measure Information:
Title
Sputum IL-8, IL-17
Time Frame
2 WEEKS
Secondary Outcome Measure Information:
Title
The expression of NF-kappa B in sputum macrophages
Time Frame
2 WEEKS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of COPD or asthma a ratio of prebronchodilator FEV1 to forced vital capacity (FVC) equal to or less than 0.70 postbronchodilator FEV1 > or = 50% predicted Exclusion Criteria: Exacerbation systemic corticosteroids DM, HIV and autoimmune disease immunosuppressive therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kittipong Maneechotesuwan, MD, PhD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kittipong Maneechotesuwan
City
Bangkoknoi
State/Province
BKK
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients

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