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

NCT ID: NCT00379730

Last Updated: 2017-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-21

Study Completion Date

2007-05-03

Brief Summary

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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).

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Interventions

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Prednisolone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Mendoza, , Argentina

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Wellington, , New Zealand

Site Status

GSK Investigational Site

Mowbray, , South Africa

Site Status

Countries

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Argentina Chile New Zealand South Africa

References

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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.

Reference Type DERIVED
PMID: 19164344 (View on PubMed)

Other Identifiers

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RES106087

Identifier Type: -

Identifier Source: org_study_id

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