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

Pfizer17 enrolled

Overview

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.

Methodology Validation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone PropionateDRUG

Dry powder for inhalation, Single Dose, 500mcg

Placebo for Fluticasone PropionateDRUG

Dry powder for inhalation, Single Dose, placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Pfizer Investigational Site

Manchester, Greater Manchester, United Kingdom

Pfizer Investigational Site

London, United Kingdom

Outcomes

Primary Outcomes

Sputum Neutrophil (%)

Time frame: 6 hours post LPS challenge

Secondary Outcomes

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

Time frame: 6 hours post LPS challenge

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

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

Sputum cells (macrophages and total cell count)

Time frame: 6 hours post LPS challenge

Data from ClinicalTrials.gov

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