Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000683639
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
21/10/2005
Date last updated
14/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of exhaled nitric oxide levels in predicting response to oral steroids in patients with COPD
Scientific title
Use of exhaled nitric oxide levels in predicting response to oral steroids in patients with COPD
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 831 0
Condition category
Condition code
Respiratory 898 898 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baseline exhaled nitric oxide levels are taken at the beginning of the study. 20mg Prednisone daily or placebo is given for 3 weeks in a cross-over design with a 4 week washout period.
Intervention code [1] 397 0
None
Comparator / control treatment
Placebo (sugar pill taken orally)
Control group
Placebo

Outcomes
Primary outcome [1] 1163 0
exercise capacity defined by 6 minute walk distance
Timepoint [1] 1163 0
Dec 08
Primary outcome [2] 1164 0
exercise capacity defined by FEV1
Timepoint [2] 1164 0
Dec 08
Secondary outcome [1] 2132 0
St George Respiratory Questionnaire score.
Timepoint [1] 2132 0
Dec 08

Eligibility
Key inclusion criteria
Patients with COPDFEV1 <70% predicted, FEV1/FVC ratio <70%Smoker or ex-smoker of at least 20 pack years.
Minimum age
40 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute exacerbation within the last 3 months, patients receiving long-term oxygen treatment.

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)
Sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Latin square design with blocking
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 183 0
New Zealand
State/province [1] 183 0

Funding & Sponsors
Funding source category [1] 989 0
Charities/Societies/Foundations
Name [1] 989 0
Health Research Council of New Zealand
Country [1] 989 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
Health Research Council of New Zealand,
PO Box 5541,
Wellesley St,
Auckland
Country
New Zealand
Secondary sponsor category [1] 853 0
University
Name [1] 853 0
University of Otago
Address [1] 853 0
University of Otago, Dunedin
Country [1] 853 0
New Zealand

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36069 0
Address 36069 0
Country 36069 0
Phone 36069 0
Fax 36069 0
Email 36069 0
Contact person for public queries
Name 9586 0
Dr Jack Dummer
Address 9586 0
Canterbury Respiratory Research Group, Department of Medicine, University of Otago, Christchurch, PO Box 4345, Christchurch.
Country 9586 0
New Zealand
Phone 9586 0
+64 3 3640640 (Ext 89682)
Fax 9586 0
Email 9586 0
jack.dummer@otago.ac.nz
Contact person for scientific queries
Name 514 0
Professor D Robin Taylor
Address 514 0
Otago Respiratory Research Group
Dunedin School of Medicine
University of Otago
PO Box 913
Dunedin
Country 514 0
New Zealand
Phone 514 0
+64 3 4740999 (Ext. 8785)
Fax 514 0
Email 514 0
robin.taylor@stonebow.otago.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.