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

NCT00400855 | Completed Phase 2

• 1 other identifier: SIG103337
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

Asthma; AMP challenge

Outcome Measures

Primary Outcomes (1)

• To characterise the dose response curve following repeat inhaled doses of FP for 5 days in the AMP challenge model.

  5 days

Secondary Outcomes (3)

• Safety following multiple AMP challenges: Adverse events

  5 days

• Plasma concentrations of FP and derived pharmacokinetic parameters

  5 days

• Exhaled nitric oxide concentrations

  5 days

Study Arms (1)

Arm 1

EXPERIMENTAL

study drug

Drug: Fluticasone propionate

Interventions

Fluticasone propionate DRUG

Study drug

Arm 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Christchurch, 8011, New Zealand

Location

GSK Investigational Site

Wellington, 6035, New Zealand

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2006
• First Posted: November 17, 2006
• Study Start: January 1, 2005
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

NZ (2)