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CompletedNCT00379730Updated Jul 11, 2017

Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 1 interventional study of Prednisolone in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 5 sites in 4 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-11.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

Prednisolone will be used as a model medication to identify new clinical outcomes for future evaluation of new therapies in short-term studies (up to 4 weeks) in patients with Chronic Obstructive Pulmonary Disease (COPD).

02

Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • CT scan
  • breathing tests
  • lung function tests
  • biomarkers
  • prednisolone
  • IOS
  • COPD
  • clinical outcomes
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 90 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  • An established clinical history of COPD
  • Evidence of bronchitis
  • Current or ex-smoker

Exclusion criteria

Exclusion Criteria:

  • COPD exacerbation requiring steroid and/or antibiotics in the last month
  • Taking oral or inhaled steroids for more than 14 days in the last 6 months
  • Unable to withhold salbutamol/albuterol for a 6 hour period
  • History of alcohol, substance or drug abuse within the last year.
  • Other significant medical condition e.g. diabetes
  • Cancer that has not been in complete remission for at least 5 years
  • As a result of the medical interview, physical examination or screening investigations, that the doctor considers the subject unfit for the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
90 participants

Interventions

  • DrugPrednisolone
06

What researchers measure

Primary outcomes

  1. lung function tests using a system called Impulse oscillometry (IOS). CT scans to measure the thickness of the tubes in the lungs Blood, sputum and breath samples to measure chemical products in the lungs and body that relate to COPD

Secondary outcomes

  1. Traditional lung function tests & Symptom Questionnaires

07

Study locations

5 sites
  • GSK Investigational Site
    Mendoza, M5500CCG, Argentina
  • GSK Investigational Site
    Santiago, Región Metro De Santiago 7500551, Chile
  • GSK Investigational Site
    Santiago, Región Metro De Santiago 7500691, Chile
  • GSK Investigational Site
    Wellington, 6035, New Zealand
  • GSK Investigational Site
    Mowbray, 7700, South Africa
08

References and documents

Publications

  • Lomas DA, Silverman EK, Edwards LD, Locantore NW, Miller BE, Horstman DH, Tal-Singer R; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints study investigators. Serum surfactant protein D is steroid sensitive and associated with exacerbations of COPD. Eur Respir J. 2009 Jul;34(1):95-102. doi: 10.1183/09031936.00156508. Epub 2009 Jan 22. PubMed 19164344 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00379730
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 22, 2006
Start date
Mar 21, 2006
Completion
May 3, 2007
Last update
Jul 11, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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