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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00369993
Registration number
NCT00369993
Ethics application status
Date submitted
28/08/2006
Date registered
30/08/2006
Date last updated
17/10/2016
Titles & IDs
Public title
Spacer Comparison In Adult Asthmatics
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Scientific title
A Randomised, Open Label, Five-way Crossover Study to Assess the Systemic Exposure of Fluticasone Propionate and Salmeterol From SERETIDE/ADVAIR 250HFA MDI Alone and With AeroChamber-Max Spacer and VOLUMATIC Both in Their Washed and Unwashed States in Adult Subjects With Mild or Intermittent Asthma
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Secondary ID [1]
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SAS104449
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - fluticasone propionate/salmeterol
Treatment: Drugs: fluticasone propionate/salmeterol
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The pharmacokinetic profile of fluticasone propionate (in particular the area under the curve to time t and the maximum concentration)
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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The pharmacokinetic profile of salmeterol and the time to maximum concentration of fluticasone propionate
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Non-smoking with a BMI of 19 - 30
- Diagnosed with mild or intermittent asthma and taking medication for it.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- Taking oral corticosteroids or inhaled fluticasone propionate
- Have certain medical conditions or are not otherwise healthy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2005
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Sample size
Target
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Spacers are used by people with respiratory diseases who have problems using MDIs (metered
dose inhalers). This study used fluticasone propionate/salmeterol to look at the
pharmacokinetic profiles produced by different spacers in their washed and un-washed states.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00369993
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Trial related presentations / publications
This study has not been published in the scientific literature.
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00369993
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