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

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).

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Mendoza, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisolone

Drug

Primary outcomes

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

Traditional lung function tests & Symptom Questionnaires

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Double-blind Study of Treatment With a Known Anti-inflammatory (Prednisolone) to Evaluate Novel Endpoints in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start: 2006
Study completion: 2007
First posted: Sep 22, 2006
Registry last updated: Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed