Skip to main content
OpenTrials
Completed

NCT Number: NCT01364519

A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers

Study to assess effect of Fluticasone Propionate on acute lung inflammation following inhaled lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers. Assessment of inflammation will be via sputum induction.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Manchester, Greater Manchester, United Kingdom

Loading trial locations.

About this study

Methodology Validation

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers
  • Normoresponsive airways - histamine PC20>16mg/mL
  • Able to complete sputum induction successfully

Exclusion criteria

  • Non (or ex) smokers
  • No LPS challenge in previous 4 weeks

Treatment and study plan

Fluticasone propionate

Drug

Dry powder for inhalation, Single Dose, 500mcg

Placebo for Fluticasone Propionate

Drug

Dry powder for inhalation, Single Dose, placebo

Primary outcomes

  1. Sputum Neutrophil (%)

    Time frame: 6 hours post LPS challenge

Secondary outcomes

  1. Sputum Inflammatory cytokines (IL-6, MCP-1 and MIP1beta)

    Time frame: 6 hours post LPS challenge

  2. Blood Inflammatory Cytokines (IL-6, MCP-1, fibrinogen, CC16, CRP and MIP1beta)

    Time frame: 1, 4 and 6 hours post LPS challenge

  3. Sputum cells (macrophages and total cell count)

    Time frame: 6 hours post LPS challenge

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Randomized, Double-Blind (3rd Party Open), Placebo-Controlled, 2-Way Crossover Study To Determine The Effects Of A Single Inhaled Dose Of 500 MCG Fluticasone Propionate On Induced Sputum Neutrophils Following Inhaled Lipopolysaccharide (LPS) Challenge In Healthy Volunteers

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2011
Registry last updated
Feb 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.