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Trial registered on ANZCTR


Registration number
ACTRN12612001111864
Ethics application status
Approved
Date submitted
16/10/2012
Date registered
17/10/2012
Date last updated
17/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of inhaled corticosteroids (ICS) on airway inflammation in chronic obstructive pulmonary disease (COPD)
Scientific title
A randomized controlled trial over 6 months to determine the effects of fluticasone propionate on lung function symptom scores, airway inflammation and airway structural remodelling in adult subjects with smoking related COPD
Secondary ID [1] 281402 0
FMS40249
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease (COPD) 287647 0
Condition category
Condition code
Respiratory 287977 287977 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inhaled fluticasone propionate versus placebo, 500mcg twice per day for 6 months
Intervention code [1] 285889 0
Treatment: Drugs
Comparator / control treatment
Lactulose powder (identical inhaler)
Control group
Placebo

Outcomes
Primary outcome [1] 288194 0
Airway inflammatory cells and structural changes in bronchial biopsies from COPD patients before and after 6 months of treatment.
Airway inflammation was assessed by immuno-staining bronchial biopsies from COPD patients for different inflammatory markers. In recent work we are addressing structural changes in airways by looking at epithelial activation in COPD.
Timepoint [1] 288194 0
at 6 months
Secondary outcome [1] 299589 0
Clinical activity of COPD patients was assessed after 6 months on treatment.
Subjects completed a Quality of Life questionnaire (St Georges Respiratory Questionnaire, SGRQ) at baseline and following the treatment period. They also recorded daily symptoms of breathlessness, sputum expectoration, cough and salbutamol use in a diary card, during the run-in and throughout the treatment period. Symptom scores were averaged over 14 days and baseline values were compared with those at the end of treatment. All subjects returned for review every two months, at which time diary cards were checked, spirometry repeated, compliance with study medication checked and the subjects were asked about any exacerbations.
Timepoint [1] 299589 0
at 6 months

Eligibility
Key inclusion criteria
FEV1/FVC < 70% post bronchodilator and no other major co-morbidities
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major confounding co-morbidities, steroids therapy in last 3 months

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5843 0
8001
Recruitment postcode(s) [2] 5844 0
7000

Funding & Sponsors
Funding source category [1] 286159 0
Government body
Name [1] 286159 0
National Health and Medical Research Council (NHMRC)
Address [1] 286159 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 286159 0
Australia
Funding source category [2] 286160 0
Commercial sector/Industry
Name [2] 286160 0
GlaxoSmithKline's (GSK)
Address [2] 286160 0
GlaxoSmithKline's (GSK)
Greenford, 980 Great West Road
Brentford, Middlesex,
TW8 9GS

United Kingdom
Country [2] 286160 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline's (GSK)
Address
GlaxoSmithKline's (GSK)
Greenford, 980 Great West Road
Brentford, Middlesex'
TW8 9GS

United Kingdom
Country
United Kingdom
Secondary sponsor category [1] 284970 0
None
Name [1] 284970 0
Address [1] 284970 0
Country [1] 284970 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of this study is to describe in better detail the airway inflammation and remodelling that we know occurs in COPD and to see what effect inhaled steroid medication has on the inflammation/structural changes and symptoms of the disease over a 6 month period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34839 0
Address 34839 0
Country 34839 0
Phone 34839 0
Fax 34839 0
Email 34839 0
Contact person for public queries
Name 18086 0
Professor E Haydn Walters
Address 18086 0
MS-1, 17 Liverpool Street, Private bag-23,
University of Tasmania, Hobart, TAS, 7000
Country 18086 0
Australia
Phone 18086 0
+61 3 6226-4870
Fax 18086 0
Email 18086 0
haydn.walters@utas.edu.au
Contact person for scientific queries
Name 9014 0
Professor E Haydn Walters
Address 9014 0
MS-1, 17 Liverpool Street, Private bag-23,
University of Tasmania, Hobart, TAS, 7000
Country 9014 0
Australia
Phone 9014 0
+61 3 6226-4870
Fax 9014 0
Email 9014 0
haydn.walters@utas.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary