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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00400855




Registration number
NCT00400855
Ethics application status
Date submitted
15/11/2006
Date registered
17/11/2006

Titles & IDs
Public title
Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate
Scientific title
A Randomised, Double-blind, Placebo-controlled, Incomplete Block, 4-period Crossover, Study to Investigate the Effects of 5-day Repeat Inhaled Doses of Fluticasone Propionate (BID, 50-2000 mcg) on Airway Responsiveness to Adenosine 5-monophosphate (AMP) Challenge When Delivered After the Last Dose in Mild Asthmatic Subjects.
Secondary ID [1] 0 0
SIG103337
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fluticasone propionate

Experimental: Arm 1 - study drug


Treatment: Drugs: Fluticasone propionate
Study drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To characterise the dose response curve following repeat inhaled doses of FP for 5 days in the AMP challenge model.
Timepoint [1] 0 0
5 days
Secondary outcome [1] 0 0
Safety following multiple AMP challenges: Adverse events
Timepoint [1] 0 0
5 days
Secondary outcome [2] 0 0
Plasma concentrations of FP and derived pharmacokinetic parameters
Timepoint [2] 0 0
5 days
Secondary outcome [3] 0 0
Exhaled nitric oxide concentrations
Timepoint [3] 0 0
5 days

Eligibility
Key inclusion criteria
* Female of non-childbearing potential
* Using appropriate contraception.
* Mild asthmatic, non (or ex) smokers.
* Has inflammatory response to AMP.
* Otherwise healthy, not using any steroids.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have a history of life-threatening asthma, defined as an asthma episode, which required intubation and/or was associated with either hypercapnea, respiratory arrest or hypoxia seizures.
* Have a known sensitivity to corticosteroids.
* Have a history of milk protein allergy.
* Test positive at the screening visit for hepatitis B or C or HIV

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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
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
1/01/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2005
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00400855