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

This study has been completed.
National Science and Technology Development Agency, Thailand
Information provided by (Responsible Party):
Kittipong Maneechotesuwan, Mahidol University Identifier:
First received: December 16, 2008
Last updated: September 10, 2013
Last verified: September 2013
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: 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


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

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
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Please refer to this study by its identifier: NCT00826163

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

Responsible Party: Kittipong Maneechotesuwan, Professor, Mahidol University Identifier: NCT00826163     History of Changes
Other Study ID Numbers: BT-B-01-MG-14-5114
Study First Received: December 16, 2008
Last Updated: September 10, 2013

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017