Innate Immune Responses in Chronic Obstructive Pulmonary... | NCT00826163

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

NCT00826163

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Sep 11, 2013Estimated

Enrollment

20Actual

Phase

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Budesonide

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 16, 2008

First Submission Date that Met QC Criteria

Jan 16, 2009

First Posted Date

Jan 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2013

Last Update Posted Date

Sep 11, 2013Estimated

Name	Class
National Science and Technology Development Agency, Thailand	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
stable COPD	Active Comparator	Postbronchodilator FEV1> or = 50% predicted	Drug: Budesonide
Asthma	Sham Comparator	Postbronchodilator FEV1 > or = 50% predicted	Drug: Budesonide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Budesonide	Drug	Inhaled budesonide 400 mcg twice a day for 2 weeks	Asthma stable COPD

Measure	Description	Time Frame
Sputum IL-8, IL-17		2 WEEKS

Measure	Description	Time Frame
The expression of NF-kappa B in sputum macrophages		2 WEEKS

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kittipong Maneechotesuwan, MD, PhD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kittipong Maneechotesuwan		Bangkoknoi	BKK	10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019819	Budesonide

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided