Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400855
• Other study ID #: SIG103337
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2006
• Last updated: September 13, 2016
• Start date: January 2005
• Est. completion date: August 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone propionate
Study drug

Locations

Country	Name	City	State
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterise the dose response curve following repeat inhaled doses of FP for 5 days in the AMP challenge model.		5 days	No
Secondary	Safety following multiple AMP challenges: Adverse events		5 days	No
Secondary	Plasma concentrations of FP and derived pharmacokinetic parameters		5 days	No
Secondary	Exhaled nitric oxide concentrations		5 days	No

External Links

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