Text Size

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

This study has been completed.
Sponsor:
Collaborator:
National Science and Technology Development Agency, Thailand
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00826163
First received: December 16, 2008
Last updated: March 12, 2010
Last verified: March 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
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:

Drug Information available for: Budesonide
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Sputum IL-8, IL-17 [ 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 ]

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

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
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

No publications provided

Responsible Party: Kittipong Maneechotesuwan Associate Professor, Division of Respiratory Disease Faculty of Medicine Siriraj Hospital
ClinicalTrials.gov Identifier: NCT00826163     History of Changes
Other Study ID Numbers: BT-B-01-MG-14-5114
Study First Received: December 16, 2008
Last Updated: March 12, 2010
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013