CClinicalTrials.gg
CompletedNCT00826163Updated Sep 11, 2013

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

A Phase 3 interventional study of Budesonide in Chronic Obstructive Pulmonary Disease, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-09-11.

Sponsored by Mahidol University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 20 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Exacerbation
  • systemic corticosteroids
  • DM, HIV and autoimmune disease
  • immunosuppressive therapy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    stable COPD

    Postbronchodilator FEV1\> or = 50% predicted

    Drug: Budesonide

  • Sham comparator
    Asthma

    Postbronchodilator FEV1 \> or = 50% predicted

    Drug: Budesonide

Interventions

  • DrugBudesonide

    Inhaled budesonide 400 mcg twice a day for 2 weeks

    Also known as: Rhinocort

06

What researchers measure

Primary outcomes

  1. Sputum IL-8, IL-17

    Time frame: 2 WEEKS

Secondary outcomes

  1. The expression of NF-kappa B in sputum macrophages

    Time frame: 2 WEEKS

07

Study locations

1 site
  • Kittipong Maneechotesuwan
    Bangkoknoi, BKK 10700, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00826163
Lead sponsor
Mahidol University
Collaborators
National Science and Technology Development Agency, Thailand
Responsible party
Kittipong Maneechotesuwan (Professor, Mahidol University) — Principal investigator
First posted
Jan 21, 2009
Start date
Jan 2009
Primary completion
Nov 2009
Completion
Dec 2009
Last update
Sep 11, 2013

Study contacts

Kittipong Maneechotesuwan, MD, PhD
principal investigator · Mahidol University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion