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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00826163
First Posted: January 21, 2009
Last Update Posted: September 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Science and Technology Development Agency, Thailand
Information provided by (Responsible Party):
Kittipong Maneechotesuwan, Mahidol University
  Purpose
We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease Drug: Budesonide Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Innate Immune Responses in Chronic Obstructive Pulmonary Disease Patients

Resource links provided by NLM:


Further study details as provided by Kittipong Maneechotesuwan, Mahidol University:

Primary Outcome Measures:
  • Sputum IL-8, IL-17 [ Time Frame: 2 WEEKS ]

Secondary Outcome Measures:
  • The expression of NF-kappa B in sputum macrophages [ Time Frame: 2 WEEKS ]

Enrollment: 20
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: stable COPD
Postbronchodilator FEV1> or = 50% predicted
Drug: Budesonide
Inhaled budesonide 400 mcg twice a day for 2 weeks
Other Name: Rhinocort
Sham Comparator: Asthma
Postbronchodilator FEV1 > or = 50% predicted
Drug: Budesonide
Inhaled budesonide 400 mcg twice a day for 2 weeks
Other Name: Rhinocort

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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): NCT00826163


Locations
Thailand
Kittipong Maneechotesuwan
Bangkoknoi, BKK, Thailand, 10700
Sponsors and Collaborators
Mahidol University
National Science and Technology Development Agency, Thailand
Investigators
Principal Investigator: Kittipong Maneechotesuwan, MD, PhD Mahidol University
  More Information

Responsible Party: Kittipong Maneechotesuwan, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT00826163     History of Changes
Other Study ID Numbers: BT-B-01-MG-14-5114
First Submitted: December 16, 2008
First Posted: January 21, 2009
Last Update Posted: September 11, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
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