NCT00826163

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2008

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 11, 2013

Status Verified

September 1, 2013

Enrollment Period

10 months

First QC Date

December 16, 2008

Last Update Submit

September 10, 2013

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Sputum IL-8, IL-17

    2 WEEKS

Secondary Outcomes (1)

  • The expression of NF-kappa B in sputum macrophages

    2 WEEKS

Study Arms (2)

stable COPD

ACTIVE COMPARATOR

Postbronchodilator FEV1\> or = 50% predicted

Drug: Budesonide

Asthma

SHAM COMPARATOR

Postbronchodilator FEV1 \> or = 50% predicted

Drug: Budesonide

Interventions

BudesonideDRUG

Inhaled budesonide 400 mcg twice a day for 2 weeks

Also known as: Rhinocort
Asthmastable COPD

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Exacerbation
  • systemic corticosteroids
  • DM, HIV and autoimmune disease
  • immunosuppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kittipong Maneechotesuwan

Bangkoknoi, BKK, 10700, Thailand

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kittipong Maneechotesuwan, MD, PhD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2008

First Posted

January 21, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

September 11, 2013

Record last verified: 2013-09

Locations

TH(1)