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

September 10, 2013 updated by: Kittipong Maneechotesuwan, Mahidol University

Innate Immune Responses in Chronic Obstructive Pulmonary Disease Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • BKK
      • Bangkoknoi, BKK, Thailand, 10700
        • Kittipong Maneechotesuwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: stable COPD
Postbronchodilator FEV1> or = 50% predicted
Drug: Budesonide
Inhaled budesonide 400 mcg twice a day for 2 weeks
Other Names:
  • Rhinocort
Sham Comparator: Asthma
Postbronchodilator FEV1 > or = 50% predicted
Drug: Budesonide
Inhaled budesonide 400 mcg twice a day for 2 weeks
Other Names:
  • Rhinocort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sputum IL-8, IL-17
Time Frame: 2 WEEKS
2 WEEKS

Secondary Outcome Measures

Outcome Measure
Time Frame
The expression of NF-kappa B in sputum macrophages
Time Frame: 2 WEEKS
2 WEEKS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

National Science and Technology Development Agency, Thailand

Investigators

  • Principal Investigator: Kittipong Maneechotesuwan, MD, PhD, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 16, 2008

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BT-B-01-MG-14-5114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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