Last updated: 11/04/2018 12:08:10
Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official 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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
To characterise the dose response curve following repeat inhaled doses of FP for 5 days in the AMP challenge model.
Timeframe: 5 days
Secondary outcomes:
Safety following multiple AMP challenges: Adverse events
Timeframe: 5 days
Plasma concentrations of FP and derived pharmacokinetic parameters
Timeframe: 5 days
Exhaled nitric oxide concentrations
Timeframe: 5 days
Interventions:
Enrollment:
49
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate
Collaborators
Not applicable
Study date(s)
January 2005 to August 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
No
- Female of non-childbearing potential
- Using appropriate contraception.
- 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.
Inclusion and exclusion criteria
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.
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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-29-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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