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

This study is enrolling participants by invitation only.

First Received: December 16, 2008 Last Updated: January 16, 2009 History of Changes

Sponsors and Collaborators:	Mahidol University National Science and Technology Development Agency, Thailand
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT00826163

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Innate Immune Responses in Chronic Obstructive Pulmonary Disease Patients

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Sputum IL-8 [ Time Frame: 2 WEEKS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The expression of NF-kappa B in sputum macrophages [ Time Frame: 2 WEEKS ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
COPD: Active Comparator Postbronchodilator FEV1> or = 50% predicted	Drug: Budesonide Inhaled budesonide 400 mcg twice a day for 2 weeks
Asthma: Sham Comparator Postbronchodilator FEV1 > or = 50% predicted	Drug: Budesonide Inhaled budesonide 400 mcg twice a day for 2 weeks

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826163

Locations

Thailand, BKK
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

Faculty of Medicine, Siriraj Hospital, Mahidol University

More Information

No publications provided

Responsible Party:	Division of Respiratory Disease Faculty of Medicine Siriraj Hospital ( Kittipong Maneechotesuwan Associate Professor )
Study ID Numbers:	BT-B-01-MG-14-5114
Study First Received:	December 16, 2008
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00826163 History of Changes
Health Authority:	Thailand: Ethical Committee

Study placed in the following topic categories:

Anti-Inflammatory Agents
Hormone Antagonists
Respiration Disorders
Budesonide
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Glucocorticoids

Hormones
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Respiration Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Hormones
Glucocorticoids

Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 11, 2009