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 (Responsible Party):
Kittipong Maneechotesuwan, Mahidol University
ClinicalTrials.gov Identifier:
NCT00826163
First received: December 16, 2008
Last updated: September 10, 2013
Last verified: September 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Professor, Mahidol University
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: September 10, 2013
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 July 29, 2014