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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01364519

Enrollment

Registered

2011-06-02

Start date

2011-07-31

Completion date

2012-01-31

Last updated

2012-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD

Brief summary

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.

Detailed description

Methodology Validation

Interventions

DRUGFluticasone Propionate

Dry powder for inhalation, Single Dose, 500mcg

DRUGPlacebo for Fluticasone Propionate

Dry powder for inhalation, Single Dose, placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Sputum Neutrophil (%)	6 hours post LPS challenge

Secondary

Measure	Time frame
Sputum Inflammatory cytokines (IL-6, MCP-1 and MIP1beta)	6 hours post LPS challenge
Blood Inflammatory Cytokines (IL-6, MCP-1, fibrinogen, CC16, CRP and MIP1beta)	1, 4 and 6 hours post LPS challenge
Sputum cells (macrophages and total cell count)	6 hours post LPS challenge

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026