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Clinical Trials/NCT00826163
NCT00826163
Completed
Phase 3

Innate Immune Responses in Chronic Obstructive Pulmonary Disease Patients

Mahidol University1 site in 1 country20 target enrollmentJanuary 2009
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ConditionsChronic Obstructive Pulmonary Disease
InterventionsBudesonide
DrugsBudesonide

Overview

Phase
Phase 3
Intervention
Budesonide
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Mahidol University
Enrollment
20
Locations
1
Primary Endpoint
Sputum IL-8, IL-17
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

We hypothesize that ongoing and more severe airway inflammation in COPD may result from the impairment in activation of innate immune response

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
December 2009
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kittipong Maneechotesuwan

Professor

Mahidol University

Eligibility 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

Arms & Interventions

stable COPD

Postbronchodilator FEV1\> or = 50% predicted

Intervention: Budesonide

Asthma

Postbronchodilator FEV1 \> or = 50% predicted

Intervention: Budesonide

Outcomes

Primary Outcomes

Sputum IL-8, IL-17

Time Frame: 2 WEEKS

Secondary Outcomes

  • The expression of NF-kappa B in sputum macrophages(2 WEEKS)

Study Sites (1)

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