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Trial registered on ANZCTR


Registration number
ACTRN12607000249459
Ethics application status
Approved
Date submitted
3/05/2007
Date registered
8/05/2007
Date last updated
8/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inhaled corticosteroids in Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
Inhaled corticosteroids (ICS) in subjects with mild to moderate Chronic Obstructive Pulmonary Disease (COPD). Does Bronchodilator reversibility and an asthmatic airway phenotype predict for ICS response?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking-related COPD 1788 0
Condition category
Condition code
Respiratory 1874 1874 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised, placebo-controlled trial of inhaled fluticasone propionate (500 Mmicrograms twice daily) over six months on airway inflammation in mild to moderate COPD.
Intervention code [1] 1736 0
Treatment: Drugs
Comparator / control treatment
The placebo is delivered via an identical metered dose inhaler device delivering a dry powder and the number of puffs and frequency are the same as the active FP arm.
Control group
Placebo

Outcomes
Primary outcome [1] 2662 0
Change in cellular airway inflammation as assessed by sputum, bronchoalveolar lavage and endobronchial biopsy.
Timepoint [1] 2662 0
Assessed at baseline and after six months intervention.
Secondary outcome [1] 4519 0
Clinical symptoms (daily diary card) and the St George's Respiratory Questionnaire.
Timepoint [1] 4519 0
Baseline and six months
Secondary outcome [2] 4520 0
Improvements in lung function.
Timepoint [2] 4520 0
Measured by spirometry at monthly intervals throughout the study.

Eligibility
Key inclusion criteria
A physician diagnosis of COPD and evidence of airflow limitation on spirometry.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants were interviewed and examined by a respiratory physician and any history suggestive of asthma, i.e. symptoms present in childhood, related atopic disorders, eczema or hay fever, significant day-to-day variability or prominent nocturnal symptoms, or a history of wheeze rather than progressive breathlessness and any previous use of ICS excluded that subject from further participation. Other exclusion criteria included significant uncontrolled co-morbidities such as diabetes, angina or cardiac failure, and other co-existing respiratory disorders, i.e. pulmonary fibrosis, lung cancer and bronchiectasis.

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)
Subjects were recruited by advertisement in local newspapers and placement of posters in clinic waiting areas in the hospital as well as on the notice boards of social and Veterans Affairs clubs. Potential participants were screened by a research nurse and physician. If eligible, they were randomised in the Hospital Pharmacy to the two trail treatments; fluticasone or placebo. The inhaled medications were dispensed from Pharmacy in identical inhaler devices and the research nurse and physician were blinded to treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised generated random number programme designed to randomise subjects to fluticasone or placebo.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients were blinded to treatment and the investigators and research nurse were blinded to treatment. Results were all analysed by researchers blinded to treatment, i.e. cell counts were undertaken on coded slides with no information whatsoevr on subject, date or treatment.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2021 0
Commercial sector/Industry
Name [1] 2021 0
GlaxoSmithKline
Country [1] 2021 0
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country
United Kingdom
Secondary sponsor category [1] 1831 0
None
Name [1] 1831 0
N/A
Address [1] 1831 0
Country [1] 1831 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3748 0
The Royal Hobart Hospital HREC
Ethics committee address [1] 3748 0
Ethics committee country [1] 3748 0
Australia
Date submitted for ethics approval [1] 3748 0
Approval date [1] 3748 0
Ethics approval number [1] 3748 0
H6532

Summary
Brief summary
The use of inhaled corticosteroids is well established in asthma, but whether they exert a beneficial effect in smoking related chronic obstructive pulmonary disease (COPD) is less clear. There are suggestions that patients with COPD who have a disease with similarities to asthma, i.e. a good spirometric response to salbutamol and a pattern of airway inflammation with predominant eosinophils (a characteristic cell in asthma), will respond more favourably to ICS. In this study, we tested our hypothesis that COPD patients with features similar to asthma, i.e. bronchodilator reversibility and an airway eosinophilia would exhibit a better response to ICS. We assessed this using airway biopsies at the beginning and end of a six month ICS study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27839 0
Address 27839 0
Country 27839 0
Phone 27839 0
Fax 27839 0
Email 27839 0
Contact person for public queries
Name 10925 0
Dr David Reid
Address 10925 0
Third Floor
School of Medicine
University of Tasmania
Collin Street
Hobart TAS 7001
Country 10925 0
Australia
Phone 10925 0
+61 3 62227043
Fax 10925 0
+61 3 62264894
Email 10925 0
[email protected]
Contact person for scientific queries
Name 1853 0
Dr David Reid
Address 1853 0
Third Floor
School of Medicine
University of Tasmania
Collin Street
Hobart TAS 7001
Country 1853 0
Australia
Phone 1853 0
+61 3 62227043
Fax 1853 0
+61 3 62264894
Email 1853 0
[email protected]

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.