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

NCT00379730 | Completed Phase 1

• 1 other identifier: RES106087
• Study Type: interventional
• Target: 90
• Locations: 4 countries
• Sites: 5

Brief 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).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

CT scan; breathing tests; lung function tests; biomarkers; prednisolone; IOS; COPD; clinical outcomes

Outcome Measures

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

Interventions

Prednisolone DRUG

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Mendoza, M5500CCG, Argentina

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7500551, Chile

Location

GSK Investigational Site

Santiago, Región Metro de Santiago, 7500691, Chile

Location

GSK Investigational Site

Wellington, 6035, New Zealand

Location

GSK Investigational Site

Mowbray, 7700, South Africa

Location

Related Publications (1)

• 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.

  PMID: 19164344 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 22, 2006
• Study Start: March 21, 2006
• Study Completion: May 3, 2007
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

CL (2); ZA (1); NZ (1); AR (1)