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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00400855
First received: November 15, 2006
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Fluticasone propionate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • Safety following multiple AMP challenges: Adverse events
  • Plasma concentrations of FP and derived pharmacokinetic parameters
  • Exhaled nitric oxide concentrations

Estimated Enrollment: 49
Study Start Date: January 2005
Intervention Details:
    Drug: Fluticasone propionate
    Other Name: Fluticasone propionate
Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400855

Locations
New Zealand
GSK Investigational Site
Christchurch, New Zealand, 8011
GSK Investigational Site
Wellington, New Zealand, 6035
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00400855     History of Changes
Other Study ID Numbers: SIG103337
Study First Received: November 15, 2006
Last Updated: May 31, 2012
Health Authority: New Zealand: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Asthma
AMP challenge

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 21, 2014