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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00379730




Registration number
NCT00379730
Ethics application status
Date submitted
20/09/2006
Date registered
22/09/2006
Date last updated
11/07/2017

Titles & IDs
Public title
Prednisolone Novel Endpoint Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Scientific 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)
Secondary ID [1] 0 0
RES106087
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Traditional lung function tests & Symptom Questionnaires
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* An established clinical history of COPD
* Evidence of bronchitis
* Current or ex-smoker
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Mendoza
Country [2] 0 0
Chile
State/province [2] 0 0
Región Metro De Santiago
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington
Country [4] 0 0
South Africa
State/province [4] 0 0
Mowbray

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT00379730
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00379730