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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
Date last updated
15/09/2016

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
Inhaling AMP causes an inflammatory response in the lung. This study will investigate whether 5-days of treatment with fluticasone propionate protects the lung from responding to the AMP in this way.
Trial website
https://clinicaltrials.gov/study/NCT00400855
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00400855