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

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Budesonide

• Registration Number: NCT00826163
• Lead Sponsor: Mahidol University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-16
• Study Start: 2009-01
• Study First Submitted QC: 2009-01-16
• Study First Posted: 2009-01-21
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-10
• Last Update Posted: 2013-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stable COPD	Budesonide	Postbronchodilator FEV1\> or = 50% predicted
Asthma	Budesonide	Postbronchodilator FEV1 \> or = 50% predicted

Primary Outcome Measures

Name	Time	Method
Sputum IL-8, IL-17	2 WEEKS

Secondary Outcome Measures

Name	Time	Method
The expression of NF-kappa B in sputum macrophages	2 WEEKS

Trial Locations

Locations (1)

Kittipong Maneechotesuwan; 🇹🇭 Bangkoknoi, BKK, Thailand