Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Fluticasone propionate (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: To characterise the dose response curve following repeat inhaled doses of FP for 5 days in the AMP challenge model.
Secondary outcome: Safety following multiple AMP challenges: Adverse eventsPlasma concentrations of FP and derived pharmacokinetic parameters Exhaled nitric oxide concentrations
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
Locations and Contacts
GSK Clinical Trials Call Center, Wellington 6400, New Zealand
Additional Information
Starting date: December 2004
Last updated: November 15, 2006
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